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Trulife

FDA UDI

Class I (US FDA UDI)

by Trulife Limited

Identity

Trade Name
Trulife FDA UDI
Generic Name
External lower-limb prosthesis suspensory component, non-powered FDA UDI
Device Name
MANUAL EXPULSION TWO PART HOUSING VALVE FDA UDI
Model / Reference
MEV350 FDA UDI
Description
MANUAL EXPULSION TWO PART HOUSING VALVE FDA UDI

Identifiers

Primary DI / UDI-DI
00645517886381 FDA UDI
FDA Product Code
ISH FDA UDI
GMDN Term
External lower-limb prosthesis suspensory component, non-powered 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Category: External lower-limb prosthesis suspensory component, non-powered

Trulife by Trulife Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External lower-limb prosthesis suspensory component, non-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trulife Limited

Sources (1)

  • FDA UDI 8f2d6a4c-bcfb-4c80-ab2d-4f7df16aff47 33 fields · synced Jun 6, 2026