REFLECTION SKY SENSITIVE NITRILE PF EXAM

GUDID D7664388232

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD7664388232
NIH Device Record Keye0705888-7c2d-4b69-9c2e-8aaef65a9de0
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTION SKY SENSITIVE NITRILE PF EXAM
Version Model Number438823
Company DUNS061081477
Company NameSmarthealth, Inc.
Device Count200
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7664388230 [Unit of Use]
HIBCCD7664388231 [Primary]
HIBCCD7664388232 [Package]
Contains: D7664388231
Package: case [12 Units]
In Commercial Distribution

FDA Product Code

LZAPolymer 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 Date2022-12-06
Device Publish Date2022-11-28

On-Brand Devices [REFLECTION SKY SENSITIVE NITRILE PF EXAM]

D7664388242438824
D7664388232438823
D7664388222438822
D7664388212438821

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