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Primo BT03

by Asp Global, LLC

Primo BT03 is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 20 Sep 2022 (UDI-DI 00840216120648), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840216120648 UDI-DI Date20 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Primo
Generic name
Traction boot
Model / reference
BT03
Primary DI / UDI-DI
00840216120648
FDA product code
FMP
GMDN term
Traction boot
Device class
Class I
Regulation number
880.6450
GUDID distribution status
In Commercial Distribution

Related devices

Category: Traction boot

Similar devices

Other devices filed under FDA product code FMP (Protector, Skin Pressure).

Other devices from Asp Global, LLC

See all devices from Asp Global, LLC →

Properties

  • Premarket exempt
Other properties (14, all answered No)