AccessGUDID - DEVICE: HLS UNI EVOLUTION (03700386913334)

GUDID

Device Identifier (DI) Information

Brand Name: HLS UNI EVOLUTION
Version or Model: GDU154
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TORNIER

Primary DI Number: 03700386913334
Issuing Agency: GS1
Commercial Distribution End Date: November 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 260324876 *Terms of Use

Device Description: No description.

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":	Yes
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?
48069	Uncoated unicondylar knee tibia prosthesis, polyethylene	A sterile implantable device designed to replace the bearing surface of one tibial condyle (tibial component) during primary or revision unicompartmental replacement of the knee joint. It is made of polyethylene (PE) and is not coated with a material intended to improve fixation and stability. The device articulates with a femoral component, 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 [?]
K022211	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: Size 5
Device Size Text, specify: Thickness 11 mm

Device Record Status

Public Device Record Key: cac7e79e-7158-4e03-bd0c-2437c97656ed
Public Version Date: October 03, 2018
Public Version Number: 4
DI Record Publish Date: October 16, 2015

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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +330476613500
Email: order@tornier.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES