AccessGUDID - DEVICE: Tornier Perform Humeral System (00840338606761)

GUDID

Device Identifier (DI) Information

Brand Name: Tornier Perform Humeral System
Version or Model: DWX6426
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWX6426
Company Name: TORNIER, INC.

Primary DI Number: 00840338606761
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, 65%

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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
Outer Diameter: 42 Millimeter
Device Size Text, specify: Thickness +6 mm
Device Size Text, specify: Size: 3 / 4

Device Record Status

Public Device Record Key: 87025d10-7c8b-40be-9942-9ef3ef782aa4
Public Version Date: December 24, 2024
Public Version Number: 1
DI Record Publish Date: December 16, 2024