AccessGUDID - DEVICE: SIGMA (10603295501992)

GUDID

Device Identifier (DI) Information

Brand Name: SIGMA
Version or Model: 1024-56-611
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102456611
Company Name: DEPUY (IRELAND)

Primary DI Number: 10603295501992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989365556 *Terms of Use

Device Description: SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 6 RM/LL 11MM

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?
48070	Unicondylar knee insert	A sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OIY	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
HRY	PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193549	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
No Device Sizes

Device Record Status

Public Device Record Key: 0e57eb4d-a327-4a1d-8d32-b5be2ecc57be
Public Version Date: May 03, 2021
Public Version Number: 1
DI Record Publish Date: April 23, 2021