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Orbit

FDA UDI

Class I (US FDA UDI)

by College Park Industries, Inc.

Identity

Trade Name
Orbit FDA UDI
Generic Name
Mechanical-resistance external ankle-foot prosthesis FDA UDI
Device Name
Orbit Foot, Left, Jet Black, Endo IP, 25cm, Category 3 FDA UDI
Model / Reference
OR LJEN 25 D3 FDA UDI
Description
Orbit Foot, Left, Jet Black, Endo IP, 25cm, Category 3 FDA UDI

Identifiers

Primary DI / UDI-DI
00195411396641 FDA UDI
FDA Product Code
ISH FDA UDI
GMDN Term
Mechanical-resistance external ankle-foot prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical-resistance external ankle-foot prosthesis

Orbit by College Park Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical-resistance external ankle-foot prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
College Park Industries, Inc.

Sources (1)

  • FDA UDI 1234eff2-f5ab-4d9e-a2ae-f9a2b9cb4126 34 fields · synced May 30, 2026