Apatech Ltd

Address:360 CENTENNIAL AVENUE,ELSTREE Hertfordshire,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

FILLER, BONE VOID, CALCIUM COMPOUND (MQV) (8) Bone grafting material, synthetic (LYC) (5) WAX,BONE (MTJ) (2)

Premarket Exempt

Clear

Actifuse Shape - 05060050780647 Catalog Number : 506005078064

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 2.6ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : LYC, MQV

Prescription Use : Yes

Device Count : 1

Actifuse Shape - 05060050780661 Catalog Number : 506005078066

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 8ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : LYC, MQV

Prescription Use : Yes

Device Count : 1

Actifuse Shape - 05060050780685 Catalog Number : 506005078068

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 15.8ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : LYC, MQV

Prescription Use : Yes

Device Count : 1

Actifuse MIS - 05060050780708 Catalog Number : 506005078070

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 7.5ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : LYC, MQV

Prescription Use : Yes

Device Count : 1

Actifuse MIS - 05060050780722 Catalog Number : 506005078072

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 7.5ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : MQV, LYC

Prescription Use : Yes

Device Count : 1

Actifuse Flow - 05060050780760 Catalog Number : 506005078076

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Actifuse Flow - 05060050780777 Catalog Number : 506005078077

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 3.0ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Actifuse Flow - 05060050780784 Catalog Number : 506005078078

Device Description : Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 5.0ml pack size

Device Class : 2

Duns Number: 221517829

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Ostene - 05413760467450 Catalog Number : 1503831

Device Description : Bone Hemostasis Material - 3.5g

Device Class : U

Duns Number: 221517829

Premarket Exempt : No

Product Code : MTJ

Prescription Use : Yes

Device Count : 1

Ostene - 05413760467467 Catalog Number : 1503832

Device Description : Bone Hemostasis Material - 2.5g

Device Class : U

Duns Number: 221517829

Premarket Exempt : No

Product Code : MTJ

Prescription Use : Yes

Device Count : 1

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