AccessGUDID - DEVICE: PyroCarbon PIP Total Joint System (00885556858417)

GUDID

Device Identifier (DI) Information

Brand Name: PyroCarbon PIP Total Joint System
Version or Model: PIP-200-20D-WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PIP-200-20D-WW
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556858417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: PIP SZ. 20 DISTAL

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?
60459	Proximal interphalangeal joint prosthesis, modular	A sterile, implantable artificial substitute for the proximal interphalangeal (PIP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. The device typically consists of proximal and distal metal (e.g., titanium) stems, which may be coated with a material (e.g., hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth, for insertion into the prepared phalanges of the joint. The stems may have articulating surfaces or there may be separate metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic ( e.g., polyethylene) articulating surface components. Dedicated tools for implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OMX	High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H010005	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: ac5e1419-a0ef-480d-8eed-e375499e8a54
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: February 10, 2023