neoheel

GUDID 06945630121821

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, single-use
Primary Device ID06945630121821
NIH Device Record Keyf0977fc6-5bb9-4250-99fa-7acf10d05ab5
Commercial Distribution StatusIn Commercial Distribution
Brand Nameneoheel
Version Model Number1060M
Company DUNS554434897
Company NameSterilance Medical (Suzhou) Inc.
Device Count50
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106945630121821 [Unit of Use]
GS116945630121828 [Primary]
GS136945630121822 [Package]
Contains: 16945630121828
Package: [4 Units]
In Commercial Distribution

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 Date2024-02-16
Device Publish Date2024-02-08

On-Brand Devices [neoheel]

369456301136291063T
369456301136121061P
369456301136051060M
369456301135991062N
369456301241061063T
069456301218211060M
369456301218151062N
369456301218081061P

Trademark Results [neoheel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEOHEEL
NEOHEEL
87024565 5443944 Live/Registered
Smiths Medical ASD, Inc.
2016-05-04

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