AccessGUDID - DEVICE: Backhaus Towel Forceps 11cm (G25003048110)

GUDID

Device Identifier (DI) Information

Brand Name: Backhaus Towel Forceps 11cm
Version or Model: 03-048-11
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03-048-11
Company Name: N S SURGICAL COMPANY

Primary DI Number: G25003048110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645681649 *Terms of Use

Device Description: A manual instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention; some types may in addition be used for compressing tubes. It is made of metallic and/or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34961	Towel clamp, reusable	A surgical instrument designed to hold together surgical towels and/or drapes, or for securing other devices such as cables/leads, during an operation/intervention. It is made of metallic or polymer materials and is available in a variety of sizes and designs (e.g., two blades joined at their midpoints, single alpha-shaped device, various gripping jaws); it is commonly known as a towel clamp, towel forceps, or towel clip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDJ	Clamp, Surgical, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Ultraviolet Light

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 11 Centimeter

Device Record Status

Public Device Record Key: a92baced-fe4f-4dae-8510-b025d3658ace
Public Version Date: February 08, 2023
Public Version Number: 1
DI Record Publish Date: January 31, 2023