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STERiLANCE SoftSure 28G

by Sterilance Medical (Suzhou) Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number16945630141291 UDI-DI Date2 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
STERiLANCE
Generic Name
Blood lancet, single-use
Model / Reference
SoftSure 28G
Primary DI / UDI-DI
16945630141291
FDA Product Code
QRK
GMDN Term
Blood lancet, single-use
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution

Other devices from Sterilance Medical (Suzhou) Inc.

See all devices from Sterilance Medical (Suzhou) Inc. →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No