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Latitude Ev™

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
LATITUDE EV™ FDA UDI
Generic Name
Elbow radius prosthesis trial FDA UDI
Model / Reference
9039004 FDA UDI

Identifiers

Catalog Number
9039004 FDA UDI
Primary DI / UDI-DI
00846832072576 FDA UDI
FDA Product Code
JDC FDA UDI
JDB FDA UDI
GMDN Term
Elbow radius prosthesis trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3150 FDA UDI
888.3160 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 55 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI

Category: Elbow radius prosthesis trial

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

Similar devices

Also classified as Elbow radius 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 51629d0c-fa0f-46a9-89ec-7e4687f18992 35 fields · synced May 31, 2026