AccessGUDID - DEVICE: Consensus Hip System (00840286804271)

GUDID

Device Identifier (DI) Information

Brand Name: Consensus Hip System
Version or Model: 1020-0-2244
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1020-0-2244
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286804271
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: Bipolar Assembly, 22mm×44mm, ±0mm

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?
33695	Bipolar femoral head outer component, hemiarthroplasty	An implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

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
No Device Sizes

Device Record Status

Public Device Record Key: 7532dff9-bfdc-4feb-afd6-2a288e03ba3b
Public Version Date: January 24, 2022
Public Version Number: 1
DI Record Publish Date: January 15, 2022