MEDTRADE PRODUCTS LIMITED

Address:ELECTRA HOUSE,CHESHIRE Cheshire East,GB

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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, Drug (FRO) (9) Dressing, Wound, Occlusive (NAD) (1)

Premarket Exempt

No Yes

Clear

Omni-stat Granules - 15060206630588 Catalog Number : FG07730591

Device Description : Hemostatic Granules. For minor external bleeding from wounds and procedures the Hemostatic Granules. For minor external bleeding from wounds and procedures the device is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. For moderate to severe external bleeding wounds the device is indicated for temporary external treatment for controlling moderate to severe bleeding.

Device Class :

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

Omni-stat Hemostatic Gauze - 15060206630595 Catalog Number : FG07734331

Device Description : Hemostatic Gauze. The device is indicated for: Temporary external treatment to c Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures.Hemostatic gauze is for temporary external use only

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

CELOX Rapid - 15060206630601 Catalog Number : FG08839061

Device Description : Hemostatic Z-fold Gauze. Dressing is indicated to control moderate to severe ble Hemostatic Z-fold Gauze. Dressing is indicated to control moderate to severe bleeding. For emergency temporary external use. For use by trained emergency responders. Chito-R technology

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

CELOX Rapid Z-Fold Gauze - MARCH CMS - 15060206630618 Catalog Number : 30-215

Device Description : Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to contro Hemostatic Z-Fold Gauze. Dressing indicated for temporary external use to control moderate to severe bleeding. For use by trained emergency responders.Chito-R Technology

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

OMNI-STAT Hemostatic Gauze - 15060206630625 Catalog Number : FG04534191

Device Description : Hemostatic Gauze: The device is indicated for: Temporary external treatment for Hemostatic Gauze: The device is indicated for: Temporary external treatment for controlling moderate to severe bleeding. Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only.

Device Class :

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

Foxseal - 15060206630632 Catalog Number : FG08814441

Device Description : Occlusive Dressing For Open Chest Wounds

Device Class :

Duns Number: 238476068

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 2

CELOX Vascular - 15060206630649 Catalog Number : FG08834081

Device Description : Hemostatic Pad: The device is indicated for the local management and control of Hemostatic Pad: The device is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16 French. The hemostatic pad is for temporary external use only.

Device Class :

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

CELOX Granules - 15060206630656 Catalog Number : FG08830441

Device Description : Hemostatic Granules: the device is indicated for the local management of bleedin Hemostatic Granules: the device is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions. The device is for temporary external use only.

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

CELOX First Aid - 15060206630663 Catalog Number : FG08834041

Device Description : Hemostatic Gauze: Hemostatic gauze dressing coated with Celox Granules. Device i Hemostatic Gauze: Hemostatic gauze dressing coated with Celox Granules. Device is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

CELOX First Aid - 15060206630670 Catalog Number : FG08834051

Device Description : Hemostatic Gauze: Hemostatic Gauze Pads coated with CELOX granules. Indicated fo Hemostatic Gauze: Hemostatic Gauze Pads coated with CELOX granules. Indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.

Device Class : U

Duns Number: 238476068

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

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