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Primo AB201L

by Asp Global, LLC

Primo AB201L is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 6 Apr 2022 (UDI-DI 00840216113374), 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 Number00840216113374 UDI-DI Date6 Apr 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  • Withdrawn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
Abdominal binder, reusable
Model / reference
AB201L
Description
Abdominal Binder - Large (55"-63")
Primary DI / UDI-DI
00840216113374
FDA product code
FSD
GMDN term
Abdominal binder, reusable
Device class
Class I
Regulation number
880.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Abdominal binder, reusable

Similar devices in this category

Other devices filed under Abdominal binder, reusable.

Other devices from Asp Global, LLC

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Properties

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