MINICOLLECT PIXIE Heel Incision Safety Lancet

GUDID 06945630109843

MINICOLLECT PIXIE Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID06945630109843
NIH Device Record Key0c133927-6065-4522-b715-8173c0de37f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMINICOLLECT PIXIE Heel Incision Safety Lancet
Version Model Number450525
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count50
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
GS106945630109843 [Unit of Use]
GS116945630109840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-04-29
Device Publish Date2021-04-21

On-Brand Devices [MINICOLLECT PIXIE Heel Incision Safety Lancet]

06945630109843MINICOLLECT PIXIE Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box
06945630109836MINICOLLECT PIXIE Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box
06945630109829MINICOLLECT PIXIE Heel Incision Safety Lancet,1.0*2.5mm,50Lancets/box

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