STERiLANCE OneStep Lancing Device

GUDID 36945630135324

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable
Primary Device ID36945630135324
NIH Device Record Keyaf33118b-e1f6-4d4f-b609-41c08767efe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERiLANCE OneStep Lancing Device
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630135309 [Primary]
GS136945630135324 [Package]
Contains: 06945630135309
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 Date2025-02-26
Device Publish Date2025-02-18

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

06945630114083 - Bard2025-03-10
36945630135324 - STERiLANCE OneStep Lancing Device2025-02-26
36945630135324 - STERiLANCE OneStep Lancing Device2025-02-26
36945630133597 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-20
36945630133603 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-20
36945630133504 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-17
36945630133511 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-17
36945630133528 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-17
36945630133535 - FIRST BLADES DISPOSABLE SURGICAL BLADES2025-01-17

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