Gentlehe

GUDID 26931918196531

One-care_for toddler_Sterile_500EA/CS

GRI Medical & Electronic Technology Co., Ltd.

Blood lancet, single-use
Primary Device ID26931918196531
NIH Device Record Keyd3797368-47c3-4412-a849-66dc9ebc6c56
Commercial Distribution StatusIn Commercial Distribution
Brand NameGentlehe
Version Model Number1414
Company DUNS679894738
Company NameGRI Medical & Electronic Technology Co., Ltd.
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com

Device Identifiers

Device Issuing AgencyDevice ID
GS116931918196534 [Primary]
GS126931918196531 [Package]
Contains: 16931918196534
Package: [50 Units]
In Commercial Distribution
GS136931918196538 [Package]
Package: [10 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 Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [Gentlehe]

26931918196531One-care_for toddler_Sterile_500EA/CS
26931918164783One-care_for Micro-preemie_Sterile_500EA/CS

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