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Tornier Perform

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Tornier Perform FDA UDI
Generic Name
Trabeculated shoulder humeral stem prosthesis FDA UDI
Device Name
US Anatomic Nucleus FDA UDI
Model / Reference
DWM001A FDA UDI
Description
US Anatomic Nucleus FDA UDI

Identifiers

Catalog Number
DWM001A FDA UDI
Primary DI / UDI-DI
00846832092178 FDA UDI
FDA Product Code
PKC FDA UDI
GMDN Term
Trabeculated shoulder humeral stem prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Trabeculated shoulder humeral stem prosthesis

Tornier Perform by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trabeculated shoulder humeral stem prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 58105620-ab93-4c63-8251-7166fabd2751 36 fields · synced May 30, 2026