Dexterity Nitrile PF Exam Blue SM 433201

GUDID D7664332012

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD7664332012
NIH Device Record Keybaebea47-338b-401a-8763-4f08975b43db
Commercial Distribution StatusIn Commercial Distribution
Brand NameDexterity Nitrile PF Exam Blue SM
Version Model Number433201
Catalog Number433201
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
HIBCCD7664332010 [Unit of Use]
HIBCCD7664332011 [Primary]
HIBCCD7664332012 [Package]
Contains: D7664332011
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 Date2022-12-01
Device Publish Date2022-11-23

Devices Manufactured by Smarthealth, Inc.

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