AccessGUDID - DEVICE: OrthoMedFlex (M7161124411100)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoMedFlex
Version or Model: 112-44-1110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORTHOMEDFLEX LLC

Primary DI Number: M7161124411100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 034442726 *Terms of Use

Device Description: Origin R Broach Size 10

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

GMDN Preferred Term Name	GMDN Definition
Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HTQ	Broach

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: 842ea6e5-fb57-48c8-968b-bcac4b5d3e16
Public Version Date: November 11, 2021
Public Version Number: 1
DI Record Publish Date: November 03, 2021