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Truform®

FDA UDI

Class II (US FDA UDI)

by Surgical Appliance Industries, Inc.

Identity

Trade Name
Truform® FDA UDI
Generic Name
Compression/pressure sock/stocking, single-use FDA UDI
Model / Reference
NV3373WH-M FDA UDI

Identifiers

Primary DI / UDI-DI
00048503837297 FDA UDI
FDA Product Code
DWL FDA UDI
GMDN Term
Compression/pressure sock/stocking, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5780 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

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

No

FDA UDI

Category: Compression/pressure sock/stocking, single-use

For individuals suffering from circulatory disorders such as venous insufficiency or deep vein thrombosis, a Compression/Pressure Sock/Stocking like Truform can provide targeted relief by applying graduated pressure to the leg and foot. This single-use device is designed for home use and clinical settings, featuring elastic material and no antimicrobial features.

Similar devices

Also classified as Compression/pressure sock/stocking, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 6fcfbafb-18ee-4dc4-92be-0587e37473df 32 fields · synced Jun 20, 2026