Cyber-Gel Glove PF Latex 1035123

GUDID H65810351232

Cyber-Gel Glove PF Latex X-Small

HENRY SCHEIN, INC.

Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile Hevea-latex examination/treatment glove, non-powdered, non-sterile
Primary Device IDH65810351232
NIH Device Record Key0adb08c1-415e-4464-a141-13682e11ce7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyber-Gel Glove PF Latex
Version Model Number1035123
Catalog Number1035123
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
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE
Special Storage Condition, SpecifyBetween 0 and 0 *FALSE

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH65810351231 [Primary]
HIBCCH65810351231 [Primary]
HIBCCH65810351231 [Primary]
HIBCCH65810351231 [Primary]
HIBCCH65810351232 [Package]
Contains: H65810351231
Package: [20 Units]
In Commercial Distribution
HIBCCH65810351232 [Package]
Contains: H65810351231
Package: [20 Units]
In Commercial Distribution
HIBCCH65810351232 [Package]
Contains: H65810351231
Package: [20 Units]
In Commercial Distribution
HIBCCH65810351232 [Package]
Contains: H65810351231
Package: [20 Units]
In Commercial Distribution
HIBCCH65810351239 [Unit of Use]
HIBCCH65810351239 [Unit of Use]
HIBCCH65810351239 [Unit of Use]
HIBCCH65810351239 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex patient examination glove
LYYLatex patient examination glove
LYYLatex patient examination glove
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 Date2020-05-21
Device Publish Date2020-05-13

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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.