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SteriGear® 10153

by H R Pharmaceuticals, Inc.

SteriGear® 10153 is a Class II device made by H R Pharmaceuticals, Inc., listed in FDA GUDID since 16 Oct 2026 (UDI-DI 00850067913245), registry data as of 2 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850067913245 UDI-DI Date16 Oct 2026ListedStatusListed 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  • Withdrawn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
SteriGear®
Generic name
Medical equipment/instrument drape, single-use
Model / reference
10153
Primary DI / UDI-DI
00850067913245
FDA product code
PUI
GMDN term
Medical equipment/instrument drape, single-use
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Other devices from H R Pharmaceuticals, Inc.

See all devices from H R Pharmaceuticals, Inc. →

Properties

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