EXALANCE LDE4 Lancing Device

GUDID 36945630125752

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable
Primary Device ID36945630125752
NIH Device Record Keyc62b4afa-1aee-4111-9485-361d5d5189a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXALANCE LDE4 Lancing Device
Version Model Number02-2201
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 Usefalse
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630125751 [Primary]
GS136945630125752 [Package]
Contains: 06945630125751
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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-02
Device Publish Date2024-04-24

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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