Skip to content

Safe Dent LAB201M-Bl

by BGSS Company Inc.

Safe Dent LAB201M-Bl is a Class I device made by BGSS Company Inc., listed in FDA GUDID since 15 May 2024 (UDI-DI 00810339031824), registry data as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810339031824 UDI-DI Date15 May 2024ListedStatusListed 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  • Withdrawn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
Safe Dent
Generic name
Isolation gown, single-use
Model / reference
LAB201M-BL
Primary DI / UDI-DI
00810339031824
FDA product code
LYU
GMDN term
Isolation gown, single-use
Device class
Class I
Regulation number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Isolation gown, single-use

Similar devices

Other devices filed under FDA product code LYU (Accessory, Surgical Apparel).

Other devices from BGSS Company Inc.

See all devices from BGSS Company Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)