GENERAL DESCRIPTION
Army Navy Retractor is used in plastic surgery to expose surface layers of skin.
Army Navy is a surgical instrument with a double-ended fenestrated handle with a
90-degree angled set of two blades.
INTENDED USE
A retractor is a surgical instrument that is used to hold back underlying organs and tissues, so that
body parts under the incision may be accessed without any fear of damage to the organs lying
at the above levels.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS Static function
instrument: retractor with handle.
Finish: Satin
Franchise: Surgical Instruments
Grade: of
Item Type: Retractors
Length - Overall (mm): 215
Length 1 - Tip/Jaw (mm): 45.5
Physician/Developer: Army-Navy
Shape: Right-Angled
Therapeutic Specialty: Rhinology
Usage: Reusable
Width 1 - Tip/Jaw (mm): 15
Packaging and labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging: - Designation of the instrument.
- Name and address and supplier (manufacturer)
Symbols used according ISO 15223 CE Mark
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.
Army Navy Retractor is used in plastic surgery to expose surface layers of skin.
Army Navy is a surgical instrument with a double-ended fenestrated handle with a
90-degree angled set of two blades.
INTENDED USE
A retractor is a surgical instrument that is used to hold back underlying organs and tissues, so that
body parts under the incision may be accessed without any fear of damage to the organs lying
at the above levels.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS Static function
instrument: retractor with handle.
Finish: Satin
Franchise: Surgical Instruments
Grade: of
Item Type: Retractors
Length - Overall (mm): 215
Length 1 - Tip/Jaw (mm): 45.5
Physician/Developer: Army-Navy
Shape: Right-Angled
Therapeutic Specialty: Rhinology
Usage: Reusable
Width 1 - Tip/Jaw (mm): 15
Packaging and labelling:
Unit presentation: individually, in protective packaging.
The following should appear on the packaging: - Designation of the instrument.
- Name and address and supplier (manufacturer)
Symbols used according ISO 15223 CE Mark
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 | $7.50 |
