DEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XL 431225

GUDID D7664312252

Smarthealth, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD7664312252
NIH Device Record Key449b80be-4cf6-4a43-ba6d-2b84c3d176b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXTERITY NITRILE PF EXAM ROYAL IN SPACESAVER BX XL
Version Model Number431225
Catalog Number431225
Company DUNS061081477
Company NameSmarthealth, Inc.
Device Count250
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
HIBCCD7664312250 [Unit of Use]
HIBCCD7664312251 [Primary]
HIBCCD7664312252 [Package]
Contains: D7664312251
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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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D766408732 - QUALITOUCH LATEX PF EXAM NATURAL CF MD2023-07-26 GLV QUALITOUCH LATEX PF EXAM NATURAL CF MED*100

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