AccessGUDID - DEVICE: Unity Total Knee System (05055343891537)

GUDID

Device Identifier (DI) Information

Brand Name: Unity Total Knee System
Version or Model: 123.081.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 123.081.00
Company Name: CORIN LTD

Primary DI Number: 05055343891537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 295437313 *Terms of Use

Device Description: Ligament Balancer Extension Attachment

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:	No
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?
46480	Orthopaedic knee-balance analyser, non-electrical	A mechanical orthopaedic device intended for measurement of the forces within the knee joint during a total knee arthroplasty (TKA) to assist with further planning of the procedure. It is typically a spring-loaded device with paddles to push against the adjacent joint surfaces and scales to display a force reading. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113060	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: ec397f3b-fce1-403e-984d-a5db2878c1e9
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: August 17, 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441285659866 ext: 2118
Email: rachel.king@coringroup.com

Phone: +441285659866 ext: 2203
Email: lucinda.gerber@coringroup.com

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