ENCOLL CORP.

Address:4576 Enterprise Street,Fremont,CA,94538,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, Collagen (KGN) (5)

Premarket Exempt

Clear

HELICOLL - 10860000744406 Catalog Number : HC2x2

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744413 Catalog Number : HC2x4

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744420 Catalog Number : HC4x4

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 4x4 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744437 Catalog Number : HC8x8

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 5

HELICOLL - 10860000744444 Catalog Number : HC0.5dia

Device Description : HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 13 mm dia disc intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

Device Class : U

Duns Number: 962858049

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 2

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