AccessGUDID - DEVICE: Omni-Fit (05051693303775)

GUDID

Device Identifier (DI) Information

Brand Name: Omni-Fit
Version or Model: Modular Femoral Head XLN (32mm Dia.)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FH3097
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693303775
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Modular Femoral Head XLN (Ceramic) 32mm Dia ( +7)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
38156	Ceramic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	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 [?]
K072101	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Room temperature and Dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 32 Millimeter

Device Record Status

Public Device Record Key: 830196c6-42f3-4c3b-bb14-fd0557b49753
Public Version Date: April 08, 2024
Public Version Number: 4
DI Record Publish Date: July 31, 2016