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Getinge Pack Sterilization Roll GUFL3030

by Pms Tibbi Cihazlar Teknolojisi Sanayi Ve Ticaret Anonim Sirketi

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850144008345 UDI-DI Date17 Dec 2017ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Getinge Pack Sterilization Roll
Generic Name
Sterilization packaging, single-use
Model / Ref / Catalog
GUFL3030, 61301606750
Primary DI / UDI-DI
00850144008345
510(k) Number
FDA Product Code
FRG, JOJ
GMDN Term
Sterilization packaging, single-use
Device Class
Class II
Regulation Number
880.6850, 880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K162362)

Show all (12)

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Properties

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

Other properties (9)

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