GenaCheck® Nitrile Powder Free Examination Glove ZC8-E19700

GUDID 00810143620115

Genabio Diagnostics Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00810143620115
NIH Device Record Keyada8fae5-3f2c-4237-a91c-4bba46e4abe8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGenaCheck® Nitrile Powder Free Examination Glove
Version Model NumberN/A
Catalog NumberZC8-E19700
Company DUNS118586095
Company NameGenabio Diagnostics 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810143620115 [Primary]
GS181014362011500 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-21
Device Publish Date2025-01-13

On-Brand Devices [GenaCheck® Nitrile Powder Free Examination Glove]

00810143620153N/A
00810143620146N/A
00810143620139N/A
00810143620115N/A

Trademark Results [GenaCheck]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GENACHECK
GENACHECK
97927680 not registered Live/Pending
Genabio Diagnostics Inc.
2023-05-09

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