AccessGUDID - DEVICE: Tornier Perform Humeral System (00846832094271)

GUDID

Device Identifier (DI) Information

Brand Name: Tornier Perform Humeral System
Version or Model: ARS1022404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ARS1022404
Company Name: TORNIER, INC.

Primary DI Number: 00846832094271
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968990812 *Terms of Use

Device Description: VE 10° Reversed Insert, 55%

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?
48092	Polyethylene reverse shoulder prosthesis cup	A sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	shoulder prosthesis, reverse configuration
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241878	000

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: Thickness -2 mm
Device Size Text, specify: Size: 3 / 4
Outer Diameter: 36 Millimeter

Device Record Status

Public Device Record Key: e5c2a64d-3447-4ad6-a657-669b46cacf34
Public Version Date: December 24, 2024
Public Version Number: 1
DI Record Publish Date: December 16, 2024