SteriLance Lancing Device Model LDE 4-AST

GUDID 06945630112706

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable
Primary Device ID06945630112706
NIH Device Record Keybb138257-0130-4399-8906-ab30a5054872
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriLance Lancing Device Model LDE 4-AST
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
GS106945630112706 [Unit of Use]
GS116945630112703 [Primary]
GS136945630112707 [Package]
Contains: 16945630112703
Package: [10 Units]
Discontinued: 2022-06-14
Not 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 Date2022-06-22
Device Publish Date2022-06-14

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

36945630121808 - neoheel2024-02-16
36945630121815 - neoheel2024-02-16
06945630121821 - neoheel2024-02-16
36945630124106 - neoheel2024-02-16
26945630122846 - Soft 2024-02-08
26945630122853 - Soft2024-02-08
26945630122860 - Soft2024-02-08
26945630122877 - Soft 2024-02-08

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