Le soothe Polychloroprene Sapphire PF EXAM LG 433469

GUDID D7664334692

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 IDD7664334692
NIH Device Record Key827cf8fc-47ef-40cd-8446-bee5efa7aaf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLe soothe Polychloroprene Sapphire PF EXAM LG
Version Model Number433469
Catalog Number433469
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
HIBCCD7664334690 [Unit of Use]
HIBCCD7664334691 [Primary]
HIBCCD7664334692 [Package]
Contains: D7664334691
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

Devices Manufactured by Smarthealth, Inc.

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