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MyGlucoHealth Lancets MGH-LCT100

by Entra Health Systems

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850081003038 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: not 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  • Withdrawn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
MyGlucoHealth Lancets
Generic Name
Blood lancet, single-use
Model / Reference
MGH-LCT100
Primary DI / UDI-DI
00850081003038
FDA Product Code
FMK
GMDN Term
Blood lancet, single-use
Device Class
Class II
Regulation Number
878.4850
GUDID distribution status
Not in Commercial Distribution

Other devices from Entra Health Systems

Properties

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

Other properties (7)

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