AccessGUDID - DEVICE: ACCLAIM (10603295067658)

GUDID

Device Identifier (DI) Information

Brand Name: ACCLAIM
Version or Model: 1722-85-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 172285000
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295067658
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: ACCLAIM LINKED POLY HUMERAL YOKE

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?
40124	Hinged total elbow prosthesis	A sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDC	PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
JDB	PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060696	000
K992656	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: c1cec548-f0ff-4c0c-b3a3-e8f6787a9a54
Public Version Date: July 19, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2015