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Defender - Small HB100S

by Primo Inc

Defender - Small HB100S is a Class I device made by Primo Inc, listed in FDA GUDID since 30 Jun 2021 (UDI-DI 00810006684018), 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 Number00810006684018 UDI-DI Date30 Jun 2021ListedStatusListed 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  • Withdrawn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
Defender - Small
Generic name
Heel protector
Model / Ref / Catalog
HB100S
Primary DI / UDI-DI
00810006684018
FDA product code
FMP
GMDN term
Heel protector
Device class
Class I
Regulation number
880.6450
GUDID distribution status
In Commercial Distribution

Similar devices

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

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)