AccessGUDID - DEVICE: OMNI Interface Acetabular System (00841690120551)

GUDID

Device Identifier (DI) Information

Brand Name: OMNI Interface Acetabular System
Version or Model: H5-12056
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H5-12056
Company Name: Omni Life Science, Inc.

Primary DI Number: 00841690120551
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061339651 *Terms of Use

Device Description: Acetabular Shell, No Hole, Hemi, 56X, E Insert

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):	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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 9dcf814b-be0a-45ec-b1fc-0e99c2e283c4
Public Version Date: September 13, 2021
Public Version Number: 4
DI Record Publish Date: November 27, 2015