Intended purpose of use: for attaching towels around the surgical incision, either with of without piercing the skin.
Product description: Towel clamp, Backhaus.
Material: martensitic stainless steel (quenched, magnetic steel) composition of carbon 0.1-1%, chromium 12-14%, molybdenum 0.2-1%, silicon 0.5-1% and manganese 0.4-2%.
Spring-type.
Hard ratchet, fine, single tooth in each jaw.
Lockable.
Length: approx. 120-125 mm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals.
Instructions for use:
Used to attach towels around the surgical field, with of without piercing the skin.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) clamp in a plastic bag.
Labelling on the primary packaging: Labelling as per regulations applied to the device.
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word "LOT"(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol).
CE mark.
Secondary packaging: Protected unit.
Four (4) Backhaus towel clamps in a box.
Labelling on the secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
Number of units per secondary packaging.
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:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods.
Environmental requirements: ISO 14001.
Product description: Towel clamp, Backhaus.
Material: martensitic stainless steel (quenched, magnetic steel) composition of carbon 0.1-1%, chromium 12-14%, molybdenum 0.2-1%, silicon 0.5-1% and manganese 0.4-2%.
Spring-type.
Hard ratchet, fine, single tooth in each jaw.
Lockable.
Length: approx. 120-125 mm.
Supplied non sterile, Hygienically packed for medical use after sterilization.
Reusable: Can withstand repeated reprocessing including steam sterilization, including manual brushing and the use of disinfectant chemicals.
Instructions for use:
Used to attach towels around the surgical field, with of without piercing the skin.
This item must be cleaned, disinfected after each use, and sterilised in a steam steriliser.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use.
One (1) clamp in a plastic bag.
Labelling on the primary packaging: Labelling as per regulations applied to the device.
Name and/of trademark and address of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word "LOT"(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol).
CE mark.
Secondary packaging: Protected unit.
Four (4) Backhaus towel clamps in a box.
Labelling on the secondary packaging:
Labelling to be the same as primary packaging.
Extra information required:
Number of units per secondary packaging.
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:
Must comply with the following standards (as per latest revision of standards):
ISO 14971:2007 Medical Devices- Application of risk management to medical devices.
ISO 7153-1:1991/Amd1:1999 Surgical instruments- Metallic material – Part 1 Stainless Steel.
ISO 13402:1995 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure.
ISO 17664:2004 Sterilization of medical devices -- Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.
ISO 7741 Instruments for surgery -- Scissors and shears -- General requirements and test methods.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.98 |
