Baxter Healthcare Corporation

Address:65 Pitts Station Road,MARION,NC,28752,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

Sealant, polymerizing (NBE) (4)

Premarket Exempt

Clear

PREVELEAK SURGICAL SEALANT - 05413765583520 Catalog Number : ADS201807

Device Description : The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory dev

Device Class :

Duns Number: 117472302

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 10

PREVELEAK SURGICAL SEALANT - 05413765583582 Catalog Number : ADS201808

Device Description : Preveleak Surgical sealant is a sealant developed to seal suture holes formed du

Device Class : 3

Duns Number: 117472302

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 1

PREVELEAK SURGICAL SEALANT - 05413765583599 Catalog Number : ADS201809

Device Description : Preveleak Surgical sealant is a sealant developed to seal suture holes formed du

Device Class : 3

Duns Number: 117472302

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 1

PREVELEAK SURGICAL SEALANT - 05413765583605 Catalog Number : ADS201810

Device Description : Preveleak Surgical sealant is a sealant developed to seal suture holes formed du

Device Class : 3

Duns Number: 117472302

Premarket Exempt : No

Product Code : NBE

Prescription Use : Yes

Device Count : 1

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