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Getinge Pack Sterilization Roll GUFL2330

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 Number00850144008314 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  • Withdrawn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
GUFL2330, 61301606749
Primary DI / UDI-DI
00850144008314
510(k) Number
FDA Product Code
JOJ, FRG
GMDN Term
Sterilization packaging, single-use
Device Class
Class II
Regulation Number
880.2800, 880.6850
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