AccessGUDID - DEVICE: OrthoMedFlex (M7161111815010)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoMedFlex
Version or Model: 111-18-1501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 111-18-1501
Company Name: ORTHOMEDFLEX LLC

Primary DI Number: M7161111815010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 034442726 *Terms of Use

Device Description: Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating

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:	Yes
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?
38155	Press-fit femoral stem prosthesis	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 74110e1d-5da1-47a1-8039-679a5b28b33f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 08, 2016