GENERAL DESCRIPTION
Ramathibodi Uterine Manipulator 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 uterine cavity during surgeries.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
manipulates uterine cavity, directing tissue as needed. useful during laparoscopic pelvic surgeries,
especially laparoscopic sterilization.
Especially includes long shanks for deep access to the tissue. In addition, the instrument has a
curved profile for better access to the uterus.
Moreover, the smooth edges of the instrument allow comfortable insertion with minimal
damage to surrounding tissue.
The manipulator has an overall length of 27.5 cm which allows it to reach the organ comfortably.
The light weight and streamlined design of the instrument decreases user fatigue. Moreover, the
finger ring handles of the Ramathibodi Uterine Manipulator allows precise control.
The streamlined built of the instrument makes it especially useful for manipulating the uterine
cavity during surgeries.
Made in premium grade stainless steel with a glare free satin finish. The instrument can be
sterilized and reused.
Instrument Profile Curved
Handle Type Ring Handle
Overall Length 27.5 cm – 11"
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 Uterine Manipulator 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 uterine cavity during surgeries.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
manipulates uterine cavity, directing tissue as needed. useful during laparoscopic pelvic surgeries,
especially laparoscopic sterilization.
Especially includes long shanks for deep access to the tissue. In addition, the instrument has a
curved profile for better access to the uterus.
Moreover, the smooth edges of the instrument allow comfortable insertion with minimal
damage to surrounding tissue.
The manipulator has an overall length of 27.5 cm which allows it to reach the organ comfortably.
The light weight and streamlined design of the instrument decreases user fatigue. Moreover, the
finger ring handles of the Ramathibodi Uterine Manipulator allows precise control.
The streamlined built of the instrument makes it especially useful for manipulating the uterine
cavity during surgeries.
Made in premium grade stainless steel with a glare free satin finish. The instrument can be
sterilized and reused.
Instrument Profile Curved
Handle Type Ring Handle
Overall Length 27.5 cm – 11"
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 | $5.28 |
