AccessGUDID - DEVICE: UniSyn® Hip System (00844588012761)

GUDID

Device Identifier (DI) Information

Brand Name: UniSyn® Hip System
Version or Model: 3473-22400-0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3473-22400-0
Company Name: CONSENSUS ORTHOPEDICS, INC.

Primary DI Number: 00844588012761
Issuing Agency: GS1
Commercial Distribution End Date: July 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 824905723 *Terms of Use

Device Description: Body, Calcar, Cementless, NP, Grit Blast

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
34032	Revision coated hip femur prosthesis	A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 24 Millimeter

Device Record Status

Public Device Record Key: ba00ad1c-ead0-4ada-8316-f46068ce2b1a
Public Version Date: July 29, 2021
Public Version Number: 3
DI Record Publish Date: October 20, 2015