BIOLIFE, L.L.C.

BIOLIFE, L.L.C.

Address:8163 25th Ct E,SARASOTA,FL,34243,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

Dressing, Wound, Drug (FRO) (10)

Premarket Exempt

No

Clear

WoundSeal® - 00834061000019 Catalog Number : WSO001

Device Description : WoundSeal® Rapid Response

Device Class : U

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

WoundSeal® - 00834061000026 Catalog Number : NCW001

Device Description : WoundSeal® + Applicator

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

WoundSeal® - 00834061000040 Catalog Number : CSU004

Device Description : WoundSeal® Powder

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 4

WoundSeal® - 00834061000057 Catalog Number : NPS001

Device Description : WoundSeal® MD + Applicator

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

StatSeal® - 00834061000064 Catalog Number : LP006

Device Description : StatSeal® Powder

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

StatSeal® - 00834061000071 Catalog Number : LP007

Device Description : StatSeal® Advanced Powder

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

WoundSeal® - 00834061000101 Catalog Number : QSO010

Device Description : WoundSeal® + Applicator

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 2

StatSeal® - 00834061000132 Catalog Number : DT013

Device Description : StatSeal® Disc - Extra Small

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

StatSeal® - 00834061000149 Catalog Number : DS014

Device Description : StatSeal® Disc - Small

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

StatSeal® - 00834061000156 Catalog Number : DM015

Device Description : StatSeal® Disc - Medium

Device Class :

Duns Number: 135872476

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

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