SteriLance Lancing Device LDE 4

GUDID 36945630113230

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable
Primary Device ID36945630113230
NIH Device Record Key7c7ae561-a4aa-4dc6-b03b-aa7deaccd59f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriLance Lancing Device LDE 4
Version Model Number02-2201
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 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
GS100694563011322 [Unit of Use]
GS116945630113236 [Primary]
GS136945630113230 [Package]
Contains: 16945630113236
Package: [10 Units]
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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-25
Device Publish Date2022-08-17

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

36945630129491 - STERiLANCE Impress Pro Disposable Safety Lancet2024-05-31
06945630126918 - STERiLANCE Elite Disposable Safety Lancet2024-05-30
06945630126925 - STERiLANCE Elite Disposable Safety Lancet2024-05-30
06945630126932 - STERiLANCE Elite Disposable Safety Lancet2024-05-30
06945630126949 - STERiLANCE Elite Disposable Safety Lancet2024-05-30
06945630126956 - STERiLANCE Elite Disposable Safety Lancet2024-05-30
06945630126963 - STERiLANCE Elite Pro Disposable Safety Lancet2024-05-30
06945630126970 - STERiLANCE Elite Pro Disposable Safety Lancet2024-05-30

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