AccessGUDID - DEVICE: U2 Hip Stem, Revision Hip Stem Collarless, Curved (04712602340755)

GUDID

Device Identifier (DI) Information

Brand Name: U2 Hip Stem, Revision Hip Stem Collarless, Curved
Version or Model: 1104-1815
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1104-1815
Company Name: UNITED ORTHOPEDIC CORP.

Primary DI Number: 04712602340755
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 656700556 *Terms of Use

Device Description: Revision hip stem, Ti plasma spray, Collarless, Curved, Right, Ø15x230mm

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?
33181	Metal-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062978	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
Device Size Text, specify: 15mm, R

Device Record Status

Public Device Record Key: 509340e0-c125-4866-b877-70ffc1f17285
Public Version Date: August 03, 2018
Public Version Number: 4
DI Record Publish Date: October 24, 2015