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Dukal 27305

by Dukal LLC

Dukal 27305 is a Class II device made by Dukal LLC, cleared under FDA 510(k) K162258 on 28 Apr 2017 and listed in FDA GUDID since 30 Mar 2022 (UDI-DI 10665973027187), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K162258

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10665973027187 UDI-DI Date30 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162258 Date28 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162258 decided 28 Apr 2017 Active
  • FDA GUDID UDI-DI 10665973027187 listed 30 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162258
  2. Listed FDA GUDID 10665973027187

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dukal
Generic name
Sterilization packaging, single-use
Model / Ref / Catalog
27305
Primary DI / UDI-DI
10665973027187
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sterilization packaging, single-use

Cleared under the same submission (K162258)

and 8 more cleared under K162258

Similar devices

Other devices filed under FDA product code FRG (Wrap, sterilization).

Other devices from Dukal LLC

See all devices from Dukal LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)