AccessGUDID - DEVICE: NA (04546540140609)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 01-14930
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-14930
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540140609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: BONE HOLDING FORCEPS

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Bone holding forceps	A surgical instrument used for grasping and holding a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Bone holding forceps

A surgical instrument used for grasping and holding a bone during a surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 17.0 Centimeter

Device Record Status

Public Device Record Key: 665773d3-6c5e-4bc8-ab1e-cfcd1cc83c11
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 08, 2016