BIOSEAL

Address:167 WEST ORANGETHORPE AVE.,PLACENTIA,CA,92870,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

TUBING, NONINVASIVE (GAZ) (5) Speculum, vaginal, nonmetal, fiberoptic (HIC) (4) Speculum, vaginal, nonmetal (HIB) (1)

Premarket Exempt

Yes

Clear

Bioseal - 00630094197012 Catalog Number :

Device Description : Levin Tube 16FR

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Bioseal - 00630094197036 Catalog Number :

Device Description : Levin Tube 14FR

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Bioseal - 00630094197043 Catalog Number :

Device Description : Levin Tube 12FR

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Bioseal - 00630094197111 Catalog Number :

Device Description : Levin Tube 16FR

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Bioseal - 00630094197180 Catalog Number :

Device Description : Levin Tube Radiopaque 18FR

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : GAZ

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094291017 Catalog Number :

Device Description : Vaginal Speculum Fiber Optic Med Wrapped

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094298016 Catalog Number :

Device Description : Vaginal Speculum Clear X-Small, Light Source

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094298023 Catalog Number :

Device Description : Vaginal Speculum Clear Small, Light Source

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094298054 Catalog Number :

Device Description : Vaginal Speculum Clear Medium, Light Source

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094298078 Catalog Number :

Device Description : Vaginal Speculum Clear Large, Light Source

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIC

Prescription Use : No

Device Count : 1

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