GENERAL DESCRIPTION
Forceps, uterine, tenaculum, Duplay, 248 mm, curved.
INTENDED USE
Schroeder Uterine Tenaculum Forceps is a specialized OB/GYN instrument that
surgeons commonly use for grasping, holding and mobilizing soft tissues and blood vessels
during gynaecological procedures.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Pressure force instrument: gripping forceps, springy.
See Martin Catalogue no. 24 Ref: 32 645 28.
Uterine traction forceps, vulsellum / tenaculum, double curved.
Hard ratchet, lockable.
Length: 28 cm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0-15-0.20% carbon, 12-13% chromium.
Reusable.
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:
Used for dressing / swabbing of vagina in preparation for surgical intervention. Also used as serving forceps (used with jar for forceps)
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
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.
Forceps, uterine, tenaculum, Duplay, 248 mm, curved.
INTENDED USE
Schroeder Uterine Tenaculum Forceps is a specialized OB/GYN instrument that
surgeons commonly use for grasping, holding and mobilizing soft tissues and blood vessels
during gynaecological procedures.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Pressure force instrument: gripping forceps, springy.
See Martin Catalogue no. 24 Ref: 32 645 28.
Uterine traction forceps, vulsellum / tenaculum, double curved.
Hard ratchet, lockable.
Length: 28 cm.
Material: Martensitic steel (quenched, magnetic steel).
Martensitic steel composition: 0-15-0.20% carbon, 12-13% chromium.
Reusable.
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:
Used for dressing / swabbing of vagina in preparation for surgical intervention. Also used as serving forceps (used with jar for forceps)
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
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 | $6.76 |
