GENERAL DESCRIPTION
Ramathibodi Tubal Hook comes with blunt tips to prevent piercing injuries to the tissues.
INTENDED USE
The streamlined built of the instrument makes it especially useful for manipulating the Fallopian
tubes during sterilization surgeries. Surgical .
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Manipulates the Fallopian tubes and pulls them through the narrow space for surgical manipulation.
Especially includes a long shank for deep access to the tissue. The tip has a ergonomic hook that slips across
the tube and pulls it for access. In addition, the instrument has a straight and slender profile for better
access to the tubes. Moreover, the smooth edges of the instrument allow comfortable insertion with
minimal damage to surrounding tissue.
The hook has an overall length of 25 cm which allows it to reach the organ comfortably.
The light weight and streamlined design of the instrument decreases user fatigue. Moreover, the broad
handle of the Ramathibodi Tubal Hook allows precise control.
The streamlined built of the instrument makes it especially useful for manipulating the Fallopian tubes
during sterilization surgeries.
Made in premium grade stainless steel with a glare free satin finish. The instrument can be sterilized and
reused.
Handle Type Solid Handle
Overall Length 25 cm – 10"
Finish Satin
Material Stainless Steel
CE Marking Yes
Reusable Yes
Packaging and labelling:
One (1) Hook in a plastic bag.
Symbols used according ISO 15223
Instructions for use: To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used to grip soft tissue
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification: Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals. ISO 7151:1988: Surgical
instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 13402:1995: Surgical and dental hand instruments - Determination of resistance against
autoclaving, corrosion and thermal exposure. ISO 17664:2017: Processing of health care products -
Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 14971:2007 Medical devices - Application of risk management to medical devices.
Environmental conditions: Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.
Ramathibodi Tubal Hook comes with blunt tips to prevent piercing injuries to the tissues.
INTENDED USE
The streamlined built of the instrument makes it especially useful for manipulating the Fallopian
tubes during sterilization surgeries. Surgical .
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Manipulates the Fallopian tubes and pulls them through the narrow space for surgical manipulation.
Especially includes a long shank for deep access to the tissue. The tip has a ergonomic hook that slips across
the tube and pulls it for access. In addition, the instrument has a straight and slender profile for better
access to the tubes. Moreover, the smooth edges of the instrument allow comfortable insertion with
minimal damage to surrounding tissue.
The hook has an overall length of 25 cm which allows it to reach the organ comfortably.
The light weight and streamlined design of the instrument decreases user fatigue. Moreover, the broad
handle of the Ramathibodi Tubal Hook allows precise control.
The streamlined built of the instrument makes it especially useful for manipulating the Fallopian tubes
during sterilization surgeries.
Made in premium grade stainless steel with a glare free satin finish. The instrument can be sterilized and
reused.
Handle Type Solid Handle
Overall Length 25 cm – 10"
Finish Satin
Material Stainless Steel
CE Marking Yes
Reusable Yes
Packaging and labelling:
One (1) Hook in a plastic bag.
Symbols used according ISO 15223
Instructions for use: To retract skin, fatty tissue, muscles of viscera during superficial surgery.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Used to grip soft tissue
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification: Classified under EU MDR 2017/745 as Class I device
Safety & product Standards:
ISO 7153-1:2016: Surgical instruments - Materials - Part 1: Metals. ISO 7151:1988: Surgical
instruments - Non-cutting, articulated instruments - General requirements and test methods.
ISO 13402:1995: Surgical and dental hand instruments - Determination of resistance against
autoclaving, corrosion and thermal exposure. ISO 17664:2017: Processing of health care products -
Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 14971:2007 Medical devices - Application of risk management to medical devices.
Environmental conditions: Storage and transport conditions: 1°C to 30°C.
Humidity: 30% RH to 70% RH.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $6.28 |
