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STERiJECT™ Low Dead Space(LDS) LDS-33013

by Tsk Laboratory International Japan KK

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04573545740510 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
STERiJECT™ Low Dead Space(LDS)
Generic Name
Hypodermic needle, single-use
Model / Reference
LDS-33013
Primary DI / UDI-DI
04573545740510
510(k) Number
FDA Product Code
QNS
GMDN Term
Hypodermic needle, single-use
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K231734)

Other devices from Tsk Laboratory International Japan KK

See all devices from Tsk Laboratory International Japan KK →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No