REGENACELL THERAPY INC

REGENACELL THERAPY INC

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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

Filler, Bone Void, Calcium Compound (MQV) (10)

Premarket Exempt

No

Clear

CellFUSE™ - 00850005961000 Catalog Number : CF-s25x25x5

Device Description : CellFUSE™ Sheet 25mm x 25mm x 5mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961017 Catalog Number : CF-s25x50x5

Device Description : CellFUSE™ Sheet 25mm x 50mm x 5mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961024 Catalog Number : CF-s25x75x5

Device Description : CellFUSE™ Sheet 25mm x 75mm x 5mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961031 Catalog Number : CF-s25x125x5

Device Description : CellFUSE™ Sheet 25mm x 125mm x 5mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961048 Catalog Number : CF-G5

Device Description : CellFUSE™ Granules 5cc

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961055 Catalog Number : CF-G10

Device Description : CellFUSE™ Granules 10cc

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961062 Catalog Number : CF-G20

Device Description : CellFUSE™ Granules 20cc

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE™ - 00850005961079 Catalog Number : CF-G30

Device Description : CellFUSE™ Granules 30cc

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE - 00850005961086 Catalog Number : CF-s25x25x3

Device Description : CellFUSE Sheet 25mm x 25mm x 3mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

CellFUSE - 00850005961093 Catalog Number : CF-s25x50x3

Device Description : CellFUSE Sheet 25mm x 50mm x 3mm

Device Class : 2

Duns Number: 018987812

Premarket Exempt : No

Product Code : MQV

Prescription Use : No

Device Count : 1

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