AccessGUDID - DEVICE: PyroCarbon PIP Total Joint System (00885556858400)

GUDID

Device Identifier (DI) Information

Brand Name: PyroCarbon PIP Total Joint System
Version or Model: PIP-200-10P-WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PIP-200-10P-WW
Company Name: Smith & Nephew, Inc.

Primary DI Number: 00885556858400
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: PIP SZ. 10 PROXIMAL

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?
62467	Surgical soft-tissue manipulation forceps, alligator, reusable	A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.	Active	false

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: 6dc830b8-9391-400c-a4b4-6aa690a40738
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: February 10, 2023