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

Bandage, Liquid (KMF) (2) Dressing, Wound, Drug (FRO) (2) Dressing, Wound, Hydrophilic (NAC) (2) Clamp, Vascular (DXC) (1)

Premarket Exempt

No Yes

Clear

mrdh bandage 10 cm x 10 cm - 00389142000117 Catalog Number :

Device Description : mrdh Bandage 10 cm x 10 cm (4" x 4")

Device Class : 1

Duns Number: 809739386

Premarket Exempt : No

Product Code : KMF

Prescription Use : Yes

Device Count : 1

mrdh Bandage 5 cm x 5 cm - 00389142000124 Catalog Number :

Device Description : mrdh bandage 5 cm x 5 cm (2 "x 2")

Device Class : 1

Duns Number: 809739386

Premarket Exempt : No

Product Code : KMF

Prescription Use : Yes

Device Count : 1

Glyko SL Patch 4 cm x 2 cm - 00389142000131 Catalog Number :

Device Description : Glyko SL Patch 4 cm x 2 cm, no foam

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Glyko SL Patch 4 cm x 4 cm - 00389142000148 Catalog Number :

Device Description : Glyko SL Patch 4 cm x 4 cm

Device Class : 1

Duns Number: 809739386

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : Yes

Device Count : 1

Syvek Excel Vascular Access Hemostasis Kit - 00389142000155 Catalog Number :

Device Description : The Syvek Excel Vascular Access Hemostasis kit contains 2 boxes of 10 handles, 1 The Syvek Excel Vascular Access Hemostasis kit contains 2 boxes of 10 handles, 10 caps and 10 alcohol prep pads each and (1) sleeve of Excel Patches (UDI 20389142000067) which contains 20 Excel Patches (UDI 00389142000063) with 20 Tegaderm The pieces are consumed together (1) handle, (1) cap, (1) alcohol prep pad, (1) Tegaderm and (1) Syvek Excel Patch.

Device Class : 2

Duns Number: 809739386

Premarket Exempt : No

Product Code : DXC

Prescription Use : Yes

Device Count : 1

Talymed 10 cm x 10 cm - 00389142000193 Catalog Number :

Device Description : Talymed 10 cm x 10 cm

Device Class : U

Duns Number: 809739386

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

Talymed dressing 5 cm x 5 cm - 00389142000209 Catalog Number :

Device Description : Talymed dressing 5 cm x 5 cm

Device Class :

Duns Number: 809739386

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

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