PAN MEDICAL US CORPORATION

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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

Arthroscope (HRX) (8)

Premarket Exempt

Clear

InterV - 15060270906268 Catalog Number : INTV-15

Device Description : 8 Gauge 15mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270906275 Catalog Number : INTV-20

Device Description : 8 Gauge 20mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV-Curve Plus - 15060270907913 Catalog Number : INTVMC-10-L

Device Description : 13 Gauge 10mm Balloon Kyphoplasty Long Catheter (Micro)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV-Curve Plus - 15060270907937 Catalog Number : INTVMC-15-L

Device Description : 13 Gauge 15mm Balloon Kyphoplasty Long Catheter (Micro)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV-Curve Plus - 15060270907944 Catalog Number : INTVMC-20-L

Device Description : 13 Gauge 20mm Balloon Kyphoplasty Long Catheter (Micro)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270908880 Catalog Number : INTVMN-10

Device Description : 11 Gauge 10mm Balloon Kyphoplasty Catheter (Mini)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270908897 Catalog Number : INTVMN-15

Device Description : 11 Gauge 15mm Balloon Kyphoplasty Catheter (Mini)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270908903 Catalog Number : INTVMN-20

Device Description : 11 Gauge 20mm Balloon Kyphoplasty Catheter (Mini)

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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