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SteriLance Neoheel Heel Incision Safety Lancet 05-108575

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 Number16945630109024 UDI-DI Date21 Dec 2020ListedStatusListed 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  • Withdrawn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 Neoheel Heel Incision Safety Lancet
Generic Name
Manual blood lancing device, single-use
Model / Reference
05-108575
Primary DI / UDI-DI
16945630109024
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

Other devices from Sterilance Medical (Suzhou) Inc.

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

Properties

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

Other properties (8)

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