AccessGUDID - DEVICE: Consensus Hip System (00840286800624)

GUDID

Device Identifier (DI) Information

Brand Name: Consensus Hip System
Version or Model: 0009-0-0015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0009-0-0015
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286800624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: Distal Centralizer, 15mm

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?
33989	Uncoated femoral stem prosthesis, one-piece	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDL	Prosthesis, hip, semi-constrained (metal cemented acetabular component)

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: 5141d9ca-549e-4fd0-9487-94ff5c9397dc
Public Version Date: January 14, 2022
Public Version Number: 1
DI Record Publish Date: January 06, 2022