Cyber-Gel Glove PF Latex 1035121

GUDID 20304040101364

Cyber-Gel Glove PF Latex X-Large

HENRY SCHEIN, INC.

Hevea-latex examination/treatment glove, non-powdered, non-sterile
Primary Device ID20304040101364
NIH Device Record Key2fff3882-5d6e-4de8-be69-2a2587d38a32
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyber-Gel Glove PF Latex
Version Model Number1035121
Catalog Number1035121
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
Device Count100
DM Exempttrue
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *FALSE

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040101360 [Unit of Use]
GS110304040101367 [Primary]
GS120304040101364 [Package]
Contains: 10304040101367
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex patient examination glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-03
Device Publish Date2019-12-26

On-Brand Devices [Cyber-Gel Glove PF Latex]

20814739020192Cyber-Gel Glove PF Latex Large
20814739020185Cyber-Gel Glove PF Latex Medium
20814739020178Cyber-Gel Glove PF Latex Small
20304040101371Cyber-Gel Glove PF Latex X-Small
20304040101364Cyber-Gel Glove PF Latex X-Large
H65810351232Cyber-Gel Glove PF Latex X-Small

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