Implantable Devices

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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

Clamp, Vascular (DXC) (10)

Premarket Exempt

Clear

SMITHWICK Carotid Shunt - 00858764006109 Catalog Number : LS1408

Device Description : Doppler Carotid Shunt 14 Fr. To 8 Fr., 15 cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006116 Catalog Number : SCS1014J

Device Description : Carotid Shunt 14 Fr. To 9 Fr., 11” long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006123 Catalog Number : SCS1014JT

Device Description : Carotid Shunt 14 Fr. To 9 Fr., With “T” port, 11” long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006130 Catalog Number : SCS1209BT

Device Description : Carotid Shunt 12 Fr. To 9 Fr. With “T” port, 15 cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006147 Catalog Number : SDS1014J

Device Description : Doppler Carotid Shunt 14 Fr. To 9 Fr., 11” long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006154 Catalog Number : SDS1014JT

Device Description : Doppler Carotid Shunt 14 Fr. To 9 Fr., With “T” port, 11” long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006161 Catalog Number : SDS1209

Device Description : Doppler Carotid Shunt 12 Fr. To 9 Fr., 15 cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006178 Catalog Number : SDS1209BT

Device Description : Doppler Carotid Shunt 12 Fr. To 9 Fr. With “T” port, 15 cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006185 Catalog Number : Twin Pack

Device Description : Two 15cm, tapered, carotid shunts. One 1408 shunt (14 Fr. to 8 Fr.) and one 1209 Two 15cm, tapered, carotid shunts. One 1408 shunt (14 Fr. to 8 Fr.) and one 1209 shunt (12 Fr. to 9 Fr.), together in one peel pack

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

SMITHWICK Carotid Shunt - 00858764006192 Catalog Number : WR1310B

Device Description : Carotid Shunt 14 Fr To 10 Fr, wire reinforced, 13cm long

Device Class : 2

Duns Number: 081364911

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

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