AccessGUDID - DEVICE: Tornier Flex Shoulder System (03700434021356)

GUDID

Device Identifier (DI) Information

Brand Name: Tornier Flex Shoulder System
Version or Model: DWH046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWH046
Company Name: TORNIER

Primary DI Number: 03700434021356
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 260324876 *Terms of Use

Device Description: Tornier Pyrocarbon Humeral Head

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?
48088	Stem-fixed metallic humeral head prosthesis	An implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QKW	Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN220012	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: Eccentric: LOW (1.5)
Outer Diameter: 46 Millimeter
Height: 17 Millimeter

Device Record Status

Public Device Record Key: 5c13f47f-5bfd-4847-b446-cb2d5b61781f
Public Version Date: March 06, 2025
Public Version Number: 2
DI Record Publish Date: January 10, 2023

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: +330476613500
Email: order@tornier.com

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