AccessGUDID - DEVICE: P.C.A. (04546540323163)

GUDID

Device Identifier (DI) Information

Brand Name: P.C.A.
Version or Model: 6728-4-940
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6728-4-940
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 04546540323163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: All Poly Patella

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
Polyethylene patella prosthesis	An artificial kneecap (patellar component) made of polyethylene (PE) and implanted during primary or revision bicondylar knee joint replacement. It is a sterile device designed to articulate with a prosthetic distal femoral component and is implanted on the back of the natural patella with bone cement.

FDA Product Code

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Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
JDL	Prosthesis, hip, semi-constrained (metal cemented acetabular component)
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964655	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

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Size Type Text
Device Size Text, specify: Size: LGE

Device Record Status

Public Device Record Key: e6fea89a-2c94-4498-a48f-1a5302e5e38c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015