Prodigy Pressure Activated Safety Lancets 24-082316

GUDID 00384840823167

Prodigy Pressure Activated Safety Lancets 26G (100 ct)

PRODIGY DIABETES CARE, LLC

Manual blood lancing device, single-use
Primary Device ID00384840823167
NIH Device Record Key5cc1eec2-4d47-49ee-9e79-4f22f4f14fa3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProdigy Pressure Activated Safety Lancets
Version Model Number24-082316
Catalog Number24-082316
Company DUNS832875905
Company NamePRODIGY DIABETES CARE, LLC
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100384840823167 [Primary]
GS130384840823168 [Package]
Package: Corrugated Box [10 Units]
In Commercial Distribution
GS190384840823160 [Unit of Use]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 Pressure Activated Safety Lancets]

30384849903380Prodigy Pressure Activated Safety Lancets 28G (100 ct)
30384840823410Prodigy Pressure Activated Safety Lancets 21G (100 ct)
00384840823167Prodigy Pressure Activated Safety Lancets 26G (100 ct)

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