Sterilance SteriHeel Plus Heel Incision Safety Lancet

GUDID 06945630110283

Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm.

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID06945630110283
NIH Device Record Keyf1b075f9-5b2b-41bc-a74e-045d07f116f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilance SteriHeel Plus Heel Incision Safety Lancet
Version Model Number30-108575
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630110283 [Unit of Use]
GS116945630110280 [Primary]

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-02
Device Publish Date2021-06-24

On-Brand Devices [Sterilance SteriHeel Plus Heel Incision Safety Lancet]

06945630110290Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.65*1.40mm.
06945630110283Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm.
3694563011501230-101428
3694563011500530-108575
3694563011499230-101025
0694563012552230-106514

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