AccessGUDID - DEVICE: CS2 Acetabular Cup System (00844588001260)

GUDID

Device Identifier (DI) Information

Brand Name: CS2 Acetabular Cup System
Version or Model: 1007-0-2848
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1007-0-2848
Company Name: CONSENSUS ORTHOPEDICS, INC.

Primary DI Number: 00844588001260
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: Acetabular Insert

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?
43168	Non-constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 28 Millimeter

Device Record Status

Public Device Record Key: 165de017-c9ae-4ae1-94ca-32a022d1f43d
Public Version Date: July 29, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2015