AccessGUDID - DEVICE: UniSyn® Hip System (00844588009136)

GUDID

Device Identifier (DI) Information

Brand Name: UniSyn® Hip System
Version or Model: 3425-11531-0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3425-11531-0
Company Name: CONSENSUS ORTHOPEDICS, INC.

Primary DI Number: 00844588009136
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: Stem, Bowed, Fluted, 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":	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?
55833	Press-fit hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck. The device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined, and is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.	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: 15 Millimeter

Device Record Status

Public Device Record Key: 434af509-0f1c-4ea0-8e5d-6f754350619f
Public Version Date: July 29, 2021
Public Version Number: 3
DI Record Publish Date: October 16, 2015