STERiLANCE Elite Disposable Safety Lancet

GUDID 06945630126918

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID06945630126918
NIH Device Record Keyad959e3d-4bd1-4a41-9bf2-e7e34b7d794d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERiLANCE Elite Disposable Safety Lancet
Version Model Number05-213015
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630126918 [Unit of Use]
GS116945630126915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-05-30
Device Publish Date2024-05-22

On-Brand Devices [STERiLANCE Elite Disposable Safety Lancet]

0694563012695605-211720B
0694563012694905-212118
0694563012693205-212618
0694563012692505-212818
0694563012691805-213015
3694563013245305-212812
3694563013246005-213012
3694563013244605-212620
3694563013243905-212118

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