AccessGUDID - DEVICE: ZUK (00885556619919)

GUDID

Device Identifier (DI) Information

Brand Name: ZUK
Version or Model: 00584201501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00584201501
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556619919
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: Femoral Size E Lt Medial/Rt Lateral

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?
33369	Uncoated unicondylar knee femur prosthesis	A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSX	PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033363	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: 32ecf69b-bbcf-4f8b-abf3-9128579dbfb1
Public Version Date: September 07, 2023
Public Version Number: 4
DI Record Publish Date: February 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)238-7538
Email: GUDID@SMITH-NEPHEW.COM

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