DEXTERITY LATEX PF EXAM NATURAL 433205

GUDID D7664332052

GLV DEXTERITY LATEX PF EXAM NATURAL XS*100

Smarthealth, Inc.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDD7664332052
NIH Device Record Key100e1d48-d9ec-4f0c-beb9-8fa36cc5820b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXTERITY LATEX PF EXAM NATURAL
Version Model Number433205
Catalog Number433205
Company DUNS061081477
Company NameSmarthealth, Inc.
Device Count100
DM Exempttrue
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com
Phone1-800-878-3929
Emailinfo@smartpractice.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7664332050 [Unit of Use]
HIBCCD7664332051 [Primary]
HIBCCD7664332052 [Package]
Contains: D7664332051
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex 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 Date2023-05-23
Device Publish Date2023-05-15

On-Brand Devices [DEXTERITY LATEX PF EXAM NATURAL]

D7664332082GLV DEXTERITY LATEX PF EXAM NATURAL LG*100
D7664332072GLV DEXTERITY LATEX PF EXAM NATURAL MED*100
D7664332062GLV DEXTERITY LATEX PF EXAM NATURAL SM*100
D7664332052GLV DEXTERITY LATEX PF EXAM NATURAL XS*100
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