AccessGUDID - DEVICE: P.F.C. SIGMA (10603295253129)

GUDID

Device Identifier (DI) Information

Brand Name: P.F.C. SIGMA
Version or Model: 98-6038
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 986038
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295253129
Issuing Agency: GS1
Commercial Distribution End Date: November 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: P.F.C. SIGMA PATELLA DOME CENTRAL PEG 38mm CEMENTED

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?
34199	Polyethylene patella prosthesis	An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: bef8cbc3-1aa1-4bb2-87c8-9d2707d449ec
Public Version Date: April 03, 2024
Public Version Number: 6
DI Record Publish Date: March 24, 2015