AccessGUDID - DEVICE: CS2 Acet. Cup Sys. - VitalitE (00840286810913)

GUDID

Device Identifier (DI) Information

Brand Name: CS2 Acet. Cup Sys. - VitalitE
Version or Model: 1724-0-3660
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1724-0-3660
Company Name: Shalby Advanced Technologies, Inc.

Primary DI Number: 00840286810913
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085976260 *Terms of Use

Device Description: Acet. Insert, Rimless, VitalitE, 36mm ID, 60mm

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?
44362	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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LHP	System, telethermographic (sole diagnostic screen)

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: 730345a8-9e21-4902-8f62-e51dc91d8ce2
Public Version Date: February 01, 2022
Public Version Number: 1
DI Record Publish Date: January 24, 2022