OneTouch SureSoft

GUDID 20353885006846

One Touch SureSoft Single Use Disposable Lancing Device

LifeScan Europe GmbH

Manual blood lancing device, single-use
Primary Device ID20353885006846
NIH Device Record Keyc43fc9c7-bf40-46b1-8cbc-3e3bf2e94abc
Commercial Distribution StatusIn Commercial Distribution
Brand NameOneTouch SureSoft
Version Model Number021-141
Company DUNS480240820
Company NameLifeScan Europe GmbH
Device Count100
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge18 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100353885006842 [Primary]
GS120353885006846 [Package]
Contains: 00353885006842
Package: [40 Units]
In Commercial Distribution
NDC/NHRIC53885-141-10 [Secondary]
GS180353885006824 [Unit of Use]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20353885006846]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

Devices Manufactured by LifeScan Europe GmbH

20353885006846 - OneTouch SureSoft2020-02-11One Touch SureSoft Single Use Disposable Lancing Device
20353885006846 - OneTouch SureSoft2020-02-11 One Touch SureSoft Single Use Disposable Lancing Device
20353885006839 - One Touch SureSoft 2020-02-11 One Touch SureSoft Single Use Disposable Lancing Device
53885-139-20 - One Touch SureSoft 2020-02-11 One Touch SureSoft Single Use Disposable Lancing Device

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