CIANNA MEDICAL, INC.

CIANNA MEDICAL, INC.

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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

Marker, Radiographic, Implantable (NEU) (9) Temporary Tissue Marker (PBY) (9)

Premarket Exempt

No

Clear

SAVI SCOUT® - 00852205006017 Catalog Number : SSR05-01

Device Description : 5 cm Delivery Needle and Reflector, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : PBY, NEU

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006024 Catalog Number : SSR75-01

Device Description : 7.5 cm Delivery Needle and Reflector, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006031 Catalog Number : SSR10-01

Device Description : 10 cm Delivery Needle and Reflector, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006048 Catalog Number : HPSU-01

Device Description : Handpiece, Single-Use, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006055 Catalog Number : SSC-01

Device Description : Console, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006062 Catalog Number : CHK-01

Device Description : Console, SCOUT® Check

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006079 Catalog Number : CHKHP-01

Device Description : Handpiece, SCOUT® Check

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006086 Catalog Number : SG-01

Device Description : Guide, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : NEU, PBY

Prescription Use : Yes

Device Count : 1

SAVI SCOUT® - 00852205006093 Catalog Number : SH-01

Device Description : Sheath, Guide, SAVI SCOUT®

Device Class : 2

Duns Number: 807876284

Premarket Exempt : No

Product Code : PBY, NEU

Prescription Use : Yes

Device Count : 1

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