AccessGUDID - DEVICE: Surpass Acetabular system (10840843106647)

GUDID

Device Identifier (DI) Information

Brand Name: Surpass Acetabular system
Version or Model: SC2642-28-46
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: GLOBUS MEDICAL, INC.

Primary DI Number: 10840843106647
Issuing Agency: GS1
Commercial Distribution End Date: June 14, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 139105691 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
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?
48055	Ceramic acetabular liner	A sterile implantable inner 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 ceramic material (e. g alumina).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRA	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, 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: c68756c5-b3bb-42c2-a9dd-89fb193ad626
Public Version Date: December 11, 2020
Public Version Number: 3
DI Record Publish Date: November 21, 2014