AccessGUDID - DEVICE: Tornier Perform® Reversed Glenoid (00846832090402)

GUDID

Device Identifier (DI) Information

Brand Name: Tornier Perform® Reversed Glenoid
Version or Model: DWJ032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWJ032
Company Name: TORNIER, INC.

Primary DI Number: 00846832090402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 968990812 *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":	Yes
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?
48093	Reverse shoulder prosthesis head	A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PHX	shoulder prosthesis, reverse configuration
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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
Outer Diameter: 36 Millimeter

Device Record Status

Public Device Record Key: fa96e404-1f90-440f-a21e-a3f550f1e41e
Public Version Date: October 16, 2023
Public Version Number: 2
DI Record Publish Date: April 25, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)494-7950
Email: customerservice@tornier.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES