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STERiLANCE SteriHeel 2 0.65mm×1.4mm

by Sterilance Medical (Suzhou) Inc.

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 Number16945630137799 UDI-DI Date19 Apr 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  • Withdrawn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
STERiLANCE
Generic Name
Manual blood lancing device, single-use
Model / Reference
"SteriHeel 2 0.65mm×1.4mm"
Primary DI / UDI-DI
16945630137799
510(k) Number
FDA Product Code
FMK
GMDN Term
Manual blood lancing device, single-use
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K210745)

Show all (12)

Other devices from Sterilance Medical (Suzhou) Inc.

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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