PRESS DISPOSABLE SAFETY LANCET

GUDID 26945630125779

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID26945630125779
NIH Device Record Key210d703a-bcfb-403a-b85d-4e29e9ef0a7e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRESS DISPOSABLE SAFETY LANCET
Version Model Number05-052118
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count13
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630125775 [Unit of Use]
GS116945630125772 [Primary]
GS126945630125779 [Package]
Contains: 16945630125772
Package: [30 Units]
In Commercial Distribution
GS136945630125776 [Package]
Package: [5 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 Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-09
Device Publish Date2024-05-01

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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