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Tornier Latitude

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Tornier Latitude FDA UDI
Generic Name
Elbow ulna prosthesis trial FDA UDI
Device Name
ULNAR STEM TRIAL FDA UDI
Model / Reference
9030302 FDA UDI
Description
ULNAR STEM TRIAL FDA UDI

Identifiers

Catalog Number
9030302 FDA UDI
Primary DI / UDI-DI
00846832015405 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Elbow ulna prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 80 Millimeter FDA UDI

Category: Elbow ulna prosthesis trial

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

Similar devices

Also classified as Elbow ulna prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI cb0f4153-c773-4bc0-8c4c-f7f5cff743aa 36 fields · synced May 30, 2026