GENERAL DESCRIPTION
Jackson Vaginal Retractor is also known as a flat-blade retractor with a curved handle to separate
the vaginal walls, allowing better visualization and easy access to the cervix.
INTENDED USE
To expose the vaginal cavity.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Length :17.8cm, Blade 3 .8cm X 7.6cm
MATERIAL: Stainless Steel
INSTRUMENT TYPE: Retractors
APPLICATION: Vaginal Retractor
BLADES: Flat Blades
HANDLE: Curve Handle
SURFACE: Satin
REUSABLE: Yes
AUTOCLAVED: Yes
RUST PREVENTION PROCEDURE: Passivated
ULTRASONIC CLEANED: Yes
TESTS PERFORMED: Boil Test, Performance Test, Shape Test
Packaging and labelling:
Primary packaging: Unit of use
One (1) retractor in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.
Any symbol used on the labelling should be in accordance of the ISO 15223- 1: 2016:
If the item has a CE marking (of equivalent), the CE logo (of equivalent) must be visible on the packaging.
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: 5°C to 40°C.
Humidity: 40% RH to 70% RH.
Jackson Vaginal Retractor is also known as a flat-blade retractor with a curved handle to separate
the vaginal walls, allowing better visualization and easy access to the cervix.
INTENDED USE
To expose the vaginal cavity.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Length :17.8cm, Blade 3 .8cm X 7.6cm
MATERIAL: Stainless Steel
INSTRUMENT TYPE: Retractors
APPLICATION: Vaginal Retractor
BLADES: Flat Blades
HANDLE: Curve Handle
SURFACE: Satin
REUSABLE: Yes
AUTOCLAVED: Yes
RUST PREVENTION PROCEDURE: Passivated
ULTRASONIC CLEANED: Yes
TESTS PERFORMED: Boil Test, Performance Test, Shape Test
Packaging and labelling:
Primary packaging: Unit of use
One (1) retractor in a plastic bag.
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonised symbol).
Information for handling, if applicable (of equivalent harmonised symbol).
Over packaging: Packaging unit
Labelling on the packaging unit: Labelling to be the same as primary packaging.
Extra information required: Number of units per box.
Any symbol used on the labelling should be in accordance of the ISO 15223- 1: 2016:
If the item has a CE marking (of equivalent), the CE logo (of equivalent) must be visible on the packaging.
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: 5°C to 40°C.
Humidity: 40% RH to 70% RH.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $8.43 |
