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) (9) Cement, Bone, Vertebroplasty (NDN) (1)

Premarket Exempt

Clear

Osteoflex - 15056033810538 Catalog Number :

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

InterV Flex Catheter - 15056033811252 Catalog Number : INTVMN-15-FL

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

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270904257 Catalog Number : INTVMC-10

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

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270904264 Catalog Number : INTVMC-15

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

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270904271 Catalog Number : INTVMC-20

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

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV Flex Catheter - 15060270904295 Catalog Number : INTVMN-20-FL

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

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270905155 Catalog Number : INTVM-10

Device Description : 10 Gauge 10mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270905179 Catalog Number : INTVM-15

Device Description : 10 Gauge 15mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270905186 Catalog Number : INTVM-20

Device Description : 10 Gauge 20mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

InterV - 15060270906251 Catalog Number : INTV-10

Device Description : 8 Gauge 10mm Balloon Kyphoplasty Catheter

Device Class : 2

Duns Number: 080228535

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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