MARINE POLYMER TECHNOLOGIES, INC.

MARINE POLYMER TECHNOLOGIES, INC.

Address:461 BOSTON ST., UNIT B5,TOPSFIELD,MA,01983,US

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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

Dressing, Wound, Hydrophilic (NAC) (5) Clamp, Vascular (DXC) (2) Bandage, Liquid (KMF) (1) Dressing, Wound, Drug (FRO) (1) Support, Patient Position (CCX) (1)

Premarket Exempt

No Yes

Clear

Syvek Radial Band - 00389142000001 Catalog Number : 420-02

Device Description : Syvek Radial Band is a vascular clamp used for radial procedures

Device Class : 2

Duns Number: 809739386

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Syvek Radial Patch - 00389142000018 Catalog Number :

Device Description : Syvek Radial Patch

Device Class :

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Syvek Brace with Straps - 00389142000032 Catalog Number :

Device Description : Syvek Brace with Straps

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

Talymed 3 cm x 3 cm - 00389142000049 Catalog Number :

Device Description : Talymed 3 cm x 3 cm

Device Class : U

Duns Number: 809739386

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

SyvekExcel Vascular Access Hemostasis System - 00389142000056 Catalog Number : 400-16-05

Device Description : SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable han SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable handle, 5 alcohol prep pads, 5 caps, 5 tegaderm and 5 Syvek Excel Patches. 4 kits are packaged in one case and sold as a unit.

Device Class : 2

Duns Number: 809739386

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Syvek Excel Patch - 00389142000063 Catalog Number :

Device Description : Syvek Excel Patch

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Glyko SL Patch 3 cm x 3 cm - 00389142000070 Catalog Number :

Device Description : Glyko SL Patch 3 cm x 3 cm

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Syvek Patch - 00389142000087 Catalog Number :

Device Description : Syvek is a 3 cm x 3 cm patch used for vascular hemostasis

Device Class : 1

Duns Number: 809739386

Premarket Exempt : No

Product Code : KMF

Prescription Use : Yes

Device Count : 1

Syvek NT Patch - 00389142000094 Catalog Number :

Device Description : Syvek NT Patch

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Syvek SP Patch - 00389142000100 Catalog Number :

Device Description : Syvek SP Patch

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

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