ROXWOOD 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

Catheter, Percutaneous (DQY) (10)

Premarket Exempt

Clear

MicroCross 18 Catheter, 135 cm, CE - 00858480007206 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

CenterCross Catheter - B094CC01000 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

CenterCross Catheter, CE - B094CCX01000 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

CenterCross Ultra LV Catheter - B094LV01000 Catalog Number :

Device Description : The CenterCross Ultra LV Catheter is intended to be used in conjunction with ste The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

MultiCross Catheter - B094MC01000 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

MultiCross Catheter, CE - B094MCX01000 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Micro14 MicroCross Catheter - B094RC00140 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Micro18 MicroCross Catheter - B094RC00180 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Micro14es MicroCross Catheter - B094RC10140 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Micro14 MicroCross Catheter, CE - B094RCX00140 Catalog Number :

Device Class : 2

Duns Number: 055819211

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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