Prodigy Adjustable Depth Lancing Device 24-083225

GUDID 00384840832251

Prodigy Adjustable Depth Lancing Device

PRODIGY DIABETES CARE, LLC

Manual blood lancing device, reusable
Primary Device ID00384840832251
NIH Device Record Key63018190-a4a3-4c32-a482-32476a800093
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy Adjustable Depth Lancing Device
Version Model Number24-083225
Catalog Number24-083225
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840832251 [Primary]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-21
Device Publish Date2018-08-21

On-Brand Devices [Prodigy Adjustable Depth Lancing Device]

00384849903556Prodigy Adjustable Depth Lancing Device
00384840832251Prodigy Adjustable Depth Lancing Device

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