AccessGUDID - DEVICE: SynFix (10705034709581)

GUDID

Device Identifier (DI) Information

Brand Name: SynFix
Version or Model: SD397.161
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD397161
Company Name: SYNTHES (U.S.A.) LP

Primary DI Number: 10705034709581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832637081 *Terms of Use

Device Description: SYNFIX-LR TRIAL RASP 8DEG DEPTH 26MM/W 32MM/H 11MM

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

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

GMDN Preferred Term Name	GMDN Definition
Bone rasp	A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Bone rasp

A hand-held, manually-operated, file-like surgical instrument with a ridged surface of coarse grooves or teeth designed to be used in surgical procedures, typically orthopaedic surgery. It is made of high-grade steel and is used to scrape and smooth the surface of bone. It will have coarse cutting ridges along all or part of the distal working end and a handle at the proximal end. A rasp differs from a file in that the grooves or teeth are much coarser than a file so that they will not clog so easily and render the instrument unusable until cleaned of the debris. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HTR	RASP

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
No Device Sizes

Device Record Status

Public Device Record Key: d5225a4a-07a4-410f-8769-dea9bf3158d9
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 31, 2016