REFLECTION POLYCHLOR PF EXAM GRN 433065

GUDID D7664330652

Smarthealth, Inc.

Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered Polychloroprene examination/treatment glove, non-powdered
Primary Device IDD7664330652
NIH Device Record Key1b86dfd7-a3bd-4423-b72c-e35264608a4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTION POLYCHLOR PF EXAM GRN
Version Model Number433065
Catalog Number433065
Company DUNS061081477
Company NameSmarthealth, 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 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
HIBCCD7664330650 [Unit of Use]
HIBCCD7664330651 [Primary]
HIBCCD7664330652 [Package]
Contains: D7664330651
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 POLYCHLOR PF EXAM GRN]

D7664330652433065
D7664330642433064
D7664330622433062

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.