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Vacuette 450041

by Greiner Bio - One GmbH

Vacuette 450041 is a Class II device made by Greiner Bio - One GmbH, cleared under FDA 510(k) K061483 on 14 Aug 2006 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 29120017570060), 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) K061483

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 Number29120017570060 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061483 Date14 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061483 decided 14 Aug 2006 Active
  • FDA GUDID UDI-DI 29120017570060 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061483
  2. Listed FDA GUDID 29120017570060

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vacuette
Generic name
Non-fixed blood collection needle
Model / Ref / Catalog
450041
Primary DI / UDI-DI
29120017570060
510(k) Number
FDA product code
FMI
GMDN term
Non-fixed blood collection needle
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Non-fixed blood collection needle.

Other devices from Greiner Bio - One GmbH

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)