OPTIM LLC

Address:64 TECHNOLOGY PARK RD.,Sturbridge,MA,01566,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Nasopharyngoscope (Flexible Or Rigid) (EOB) (9) Led Light Source (NTN) (1)

Premarket Exempt

Clear

ENTity XL Nasopharyngoscope - 00085119004132 Catalog Number :

Device Description : ENTity XL NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENTity Nasopharyngoscope - 00858119004002 Catalog Number :

Device Description : ENTity Nasoview Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENT 3.6FL30 Nasopharyngoscope - 00858119004019 Catalog Number :

Device Description : ENT 3.6FL30 Flexible Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENT 3.6FP30 Nasopharyngoscope - 00858119004026 Catalog Number :

Device Description : ENT 3.6FP30 Flexible Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

Portable Light Source - 00858119004101 Catalog Number :

Device Description : LED Portable Light Source

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : NTN

Prescription Use : Yes

Device Count : 1

ENTity SD Nasopharyngoscope - 00858119004125 Catalog Number :

Device Description : ENTity SD NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENTity XL Nasopharyngoscope - 00858119004132 Catalog Number :

Device Description : ENTity XL NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENTity SD 45X Nasopharyngoscope - 00858119004149 Catalog Number :

Device Description : ENTity SD 45X NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENTity SDXL Nasopharyngoscope - 00858119004156 Catalog Number :

Device Description : ENTity SDXL NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

ENTity SDXL 45X Nasopharyngoscope - 00858119004163 Catalog Number :

Device Description : ENTity SDXL 45X NasoView Flexible LED Nasopharyngoscope

Device Class : 2

Duns Number: 052927001

Premarket Exempt : No

Product Code : EOB

Prescription Use : Yes

Device Count : 1

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