AccessGUDID - DEVICE: Novation Ceramic AHS (10885862025531)

GUDID

Device Identifier (DI) Information

Brand Name: Novation Ceramic AHS
Version or Model: 140-36-14
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 140-36-14
Company Name: Exactech, Inc.

Primary DI Number: 10885862025531
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 157565946 *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
Device Size Text, specify: Group 4
Lumen/Inner Diameter: 36 Millimeter

Device Record Status

Public Device Record Key: 8d01b948-2677-4f4b-8173-efca0bd9d777
Public Version Date: July 22, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2014