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Daniels 1001107504

by Daniels Corporation International Pty Ltd

Daniels 1001107504 is a Class II device made by Daniels Corporation International Pty Ltd, cleared under FDA 510(k) K001337 on 5 Jul 2000 and listed in FDA GUDID since 2 May 2018 (UDI-DI 09333990000073), 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) K001337

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 Number09333990000073 UDI-DI Date2 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001337 Date5 Jul 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001337 decided 5 Jul 2000 Active
  • FDA GUDID UDI-DI 09333990000073 listed 2 May 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001337
  2. Listed FDA GUDID 09333990000073

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Daniels
Generic name
Sharps container
Model / reference
1001107504
Primary DI / UDI-DI
09333990000073
510(k) Number
FDA product code
MMK
GMDN term
Sharps container
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MMK (Container, Sharps).

Other devices from Daniels Corporation International Pty Ltd

See all devices from Daniels Corporation International Pty Ltd →

Properties

  • Serial number
Other properties (14, all answered No)