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Premier 8448

by Hollister Incorporated

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00610075001002 UDI-DI Date1 Dec 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Premier
Generic Name
One-piece urostomy bag, open-ended, single-use
Model / Ref / Catalog
8448
Primary DI / UDI-DI
00610075001002
FDA Product Code
EXG
GMDN Term
One-piece urostomy bag, open-ended, single-use
Device Class
Class I
Regulation Number
876.5900
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 32 Millimeter

Related devices

Category: One-piece urostomy bag, open-ended

Other devices from Hollister Incorporated

See all devices from Hollister Incorporated →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No