REFLECTION LATEX PF EXAM GRN LG 43211

GUDID D766432112

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Primary Device ID	D766432112
NIH Device Record Key	e8c2ea8d-0a45-4094-90af-6aacc2a775cd
Commercial Distribution Status	In Commercial Distribution
Brand Name	REFLECTION LATEX PF EXAM GRN LG
Version Model Number	43211
Catalog Number	43211
Company DUNS	061081477
Company Name	Smarthealth, Inc.
Device Count	100
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Issuing Agency	Device ID
HIBCC	D766432110 [Unit of Use]
HIBCC	D766432111 [Primary]
HIBCC	D766432112 [Package] Contains: D766432111 Package: case [10 Units] In Commercial Distribution

LYY	Latex Patient Examination Glove

Steralize Prior To Use	false
Device Is Sterile	false

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