AccessGUDID - DEVICE: NEUFLEX (10603295017912)

GUDID

Device Identifier (DI) Information

Brand Name: NEUFLEX
Version or Model: 1233-30-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 123330000
Company Name: DEPUY ORTHOPAEDICS, INC.

Primary DI Number: 10603295017912
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080506581 *Terms of Use

Device Description: NEUFLEX FINGER-PIP IMPLANT 3 CEMENTLESS

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?
33697	Proximal interphalangeal joint prosthesis, one-piece	A sterile implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYJ	PROSTHESIS, FINGER, CONSTRAINED, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001922	000
K083107	000
K970544	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: 85fbf168-af4c-4c02-afee-b0ff66bc2190
Public Version Date: March 31, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2015