Sterilance Flex3 Depth Adjustable Safety Lancet

GUDID 36945630111908

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID36945630111908
NIH Device Record Key21cfe651-f045-4656-b818-ea3370110514
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilance Flex3 Depth Adjustable Safety Lancet
Version Model Number05-1526A
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count1000
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630111907 [Unit of Use]
GS116945630111904 [Primary]
GS136945630111908 [Package]
Contains: 16945630111904
Package: [1000 Units]
Discontinued: 2022-03-10
Not in Commercial Distribution

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-18
Device Publish Date2022-03-10

On-Brand Devices [Sterilance Flex3 Depth Adjustable Safety Lancet]

06945630109010Sterilance Flex3 Depth Adjustable Safety Lancet,26G 1.3mm/1.8mm/2.3mm,100Lancets/box
3694563011197705-052618
3694563011192205-1528A
3694563011191505-1530A
3694563011190805-1526A
3694563011189205-1523A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.