AccessGUDID - DEVICE: UHR (07613327017410)

GUDID

Device Identifier (DI) Information

Brand Name: UHR
Version or Model: UH1-61-28
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UH1-61-28
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327017410
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Bipolar Component

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

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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
Femoral head bipolar component	A sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

GMDN Preferred Term Name

GMDN Definition

Femoral head bipolar component

A sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

FDA Product Code

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Product Code	Product Code Name
KWL	Prosthesis, hip, hemi-, femoral, metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K800207	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 61.0 Millimeter
Lumen/Inner Diameter: 28.0 Millimeter

Device Record Status

Public Device Record Key: d572943d-4cd3-46c2-97bb-843d7de94b20
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015