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Abdominal Binder AB201M

by Primo Inc

Abdominal Binder AB201M is a Class I device made by Primo Inc, listed in FDA GUDID since 27 Feb 2019 (UDI-DI 00810006681116), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810006681116 UDI-DI Date27 Feb 2019ListedStatusListed 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  • Withdrawn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
Abdominal Binder
Generic name
Abdominal binder, single-use
Model / Ref / Catalog
AB201M
Primary DI / UDI-DI
00810006681116
FDA product code
FSD
GMDN term
Abdominal binder, single-use
Device class
Class I
Regulation number
880.5160
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code FSD (Binder, Abdominal).

Other devices from Primo Inc

See all devices from Primo Inc →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)