Soft Twist Lancets 01-0132

GUDID 36945630122478

Soft 32G

Sterilance Medical (Suzhou) Inc.

Blood lancet, single-use
Primary Device ID36945630122478
NIH Device Record Keyf596197a-d27d-4b60-852d-179c7fafa946
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoft Twist Lancets
Version Model Number01-0132
Catalog Number01-0132
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count100
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630122477 [Unit of Use]
GS116945630122474 [Primary]
GS136945630122478 [Package]
Contains: 16945630122474
Package: Case [50 Units]
In Commercial Distribution

FDA Product Code

QRKSingle Use Only Blood Lancet Without 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 Date2023-12-11
Device Publish Date2023-12-01

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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