AccessGUDID - DEVICE: 11mm STAR E+ Sliding Core STAR Total Ankle (00810028393523)

GUDID

Device Identifier (DI) Information

Brand Name: 11mm STAR E+ Sliding Core STAR Total Ankle
Version or Model: 602-03-011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Trilliant Surgical, LLC

Primary DI Number: 00810028393523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828829072 *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):	No
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?
48180	Ankle prosthesis bearing	A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050050	024

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: ed05bd16-602d-4c1f-99dc-1f568845ca34
Public Version Date: August 14, 2024
Public Version Number: 1
DI Record Publish Date: August 06, 2024