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

Drape, surgical, exempt (PUI) (7) Speculum, vaginal, nonmetal (HIB) (3)

Premarket Exempt

Yes

Clear

Bioseal Inc. - 00630094015385 Catalog Number :

Device Description : Impervious Stockinette 12"x60" CSR Wrapped

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094018263 Catalog Number :

Device Description : Drape Fenestrated Polylined STERILE

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094036823 Catalog Number :

Device Description : Stockinette Tubular 6"x48" 2ply Folded White

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094101187 Catalog Number :

Device Description : Vaginal Speculum Fiber Optic Small w/ Sheath

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094102184 Catalog Number :

Device Description : Vaginal Speculum Fiber Optic Medium w/ Sheath

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094103181 Catalog Number :

Device Description : Vaginal Speculum Fiber Optic Large w/ Sheath

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : HIB

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094118260 Catalog Number :

Device Description : Circumcision Drape 1" Bulk Non Sterile

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094118291 Catalog Number :

Device Description : Poly Drape 29.5" x 29.5"

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094121239 Catalog Number :

Device Description : Impervious Stockinette 9" Bulk Non Sterile

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Bioseal Inc. - 00630094123158 Catalog Number :

Device Description : Stockinette Tubular 3"x36" 1ply CSR Wrapped

Device Class : 2

Duns Number: 186968939

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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