Illusion Glove Strawberry 1124991

GUDID H65811249912

Illusion Glove Strawberry 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 IDH65811249912
NIH Device Record Key2b7e6ec4-bb5a-4530-a9bd-ab327323009e
Commercial Distribution StatusIn Commercial Distribution
Brand NameIllusion Glove Strawberry
Version Model Number1124991
Catalog Number1124991
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
HIBCCH65811249911 [Primary]
HIBCCH65811249911 [Primary]
HIBCCH65811249911 [Primary]
HIBCCH65811249911 [Primary]
HIBCCH65811249912 [Package]
Contains: H65811249911
Package: [20 Units]
In Commercial Distribution
HIBCCH65811249912 [Package]
Contains: H65811249911
Package: [20 Units]
In Commercial Distribution
HIBCCH65811249912 [Package]
Contains: H65811249911
Package: [20 Units]
In Commercial Distribution
HIBCCH65811249912 [Package]
Contains: H65811249911
Package: [20 Units]
In Commercial Distribution
HIBCCH65811249919 [Unit of Use]
HIBCCH65811249919 [Unit of Use]
HIBCCH65811249919 [Unit of Use]
HIBCCH65811249919 [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 [Illusion Glove Strawberry]

20304040101517Illusion Glove Strawberry Small
20304040101500Illusion Glove Strawberry Medium
20304040101494Illusion Glove Strawberry Large
20304040101487Illusion Glove Strawberry X-Small
H65811249942Illusion Glove Strawberry Large
H65811249912Illusion Glove Strawberry X-Small

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