EXSURCO MEDICAL, INC.

Address:10804 GREEN RD,Wakeman,OH,44889,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

Dermatome (GFD) (10)

Premarket Exempt

Yes

Clear

Amalgatome SD Pneumatic Hose - 00810006780000 Catalog Number : X101004

Device Description : Pneumatic Hose ASD

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD Hand Piece (Drive Unit) - 00810006780017 Catalog Number : X101016

Device Description : Drive Unit ASD

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD Sterilization Tray - 00810006780024 Catalog Number : X101005

Device Description : Sterilization tray

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD 2-inch Cutting Head - 00810006780031 Catalog Number : X100968

Device Description : Blade Head 2" ASD; Excision ring blade head

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD 4-inch Cutting Head - 00810006780048 Catalog Number : X100969

Device Description : Blade Head 4" ASD; Excision ring blade head

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD 2-inch Lock Ring - 00810006780055 Catalog Number : X100768

Device Description : Lock Ring 2" ASD

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

Amalgatome SD 4-inch Lock Ring - 00810006780062 Catalog Number : X100825

Device Description : Lock Ring 4" ASD

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

4-inch ASD Excision ring blade - 00810006780079 Catalog Number : X101788

Device Description : Amalgatome SD Surgical Skin Grafting and Debridement Blade

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 5

2-inch ASD Excision ring blade - 00810006780086 Catalog Number : X101789

Device Description : Amalgatome SD Surgical Skin Grafting and Debridement Blade

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 5

Amalgatome SD System (2" & 4") - 00810006780093 Catalog Number : SDSYSTEM024

Device Description : Amalgatome SD System (2" & 4")

Device Class : 1

Duns Number: 079319210

Premarket Exempt : Yes

Product Code : GFD

Prescription Use : Yes

Device Count : 1

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