SteriLance OneStep

GUDID 36945630123482

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable
Primary Device ID36945630123482
NIH Device Record Keyd4055af5-8bb9-4ad7-a78f-6a623b566318
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriLance OneStep
Version Model Number02-2401
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS116945630123488 [Primary]
GS136945630123482 [Package]
Contains: 16945630123488
Package: [100 Units]
In Commercial Distribution

FDA Product Code

QRLMultiple Use Blood Lancet For Single Patient Use Only

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-23
Device Publish Date2024-01-15

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

36945630132439 - STERiLANCE Elite Disposable Safety Lancet2024-10-31
36945630132446 - STERiLANCE Elite Disposable Safety Lancet2024-10-31
36945630132460 - STERiLANCE Elite Disposable Safety Lancet2024-10-31
36945630132477 - STERiLANCE Press2 Disposable Safety Lancet2024-10-31
36945630132484 - STERiLANCE Press2 Disposable Safety Lancet2024-10-31
36945630132491 - STERiLANCE Press2 Disposable Safety Lancet2024-10-31
36945630132507 - STERiLANCE Press2 Disposable Safety Lancet2024-10-31
36945630132514 - STERiLANCE Flex3 Disposable Safety Lancet2024-10-31

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