Sterilance Press Safety Lancet 26G 1.8mm

GUDID 36945630123093

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID36945630123093
NIH Device Record Keyfc50b55b-3719-4728-8738-62104f99d9de
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilance Press Safety Lancet 26G 1.8mm
Version Model Number05-052618
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630123092 [Unit of Use]
GS116945630123099 [Primary]
GS136945630123093 [Package]
Contains: 16945630123099
Package: [10 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 Date2024-01-23
Device Publish Date2024-01-15

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

26945630125779 - PRESS DISPOSABLE SAFETY LANCET2024-05-09
36945630125752 - EXALANCE LDE4 Lancing Device2024-05-02
06945630125522 - STERiLANCE SteriHeel Plus Heel Incision Safety Lancet2024-04-17
26945630125120 - Disposable Safety Lancet Press2 2024-04-08
36945630121808 - neoheel2024-02-16
36945630121815 - neoheel2024-02-16
06945630121821 - neoheel2024-02-16
36945630124106 - neoheel2024-02-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.