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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
Coated elbow humerus prosthesis FDA UDI
Model / Reference
0030701 FDA UDI

Identifiers

Catalog Number
0030701 FDA UDI
Primary DI / UDI-DI
00846832074693 FDA UDI
FDA Product Code
JDB FDA UDI
JDC FDA UDI
GMDN Term
Coated elbow humerus prosthesis FDA UDI

Classification

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

Dimensions & Sizes

Size
Length — 72 Millimeter FDA UDI

Category: Coated elbow humerus prosthesis

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

Similar devices

Also classified as Coated elbow humerus 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 73d39e9e-f671-424f-9ae8-89574a464dff 35 fields · synced May 30, 2026