BERKELEY ADVANCED BIOMATERIALS, LLC

Address:2800 Seventh Street,Berkeley,CA,94710,US

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- Catalog Number : NBF1-50X10-01

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF2-50X10-02

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF1-50X10-02

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF2-50X10-05

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF2-50X25-10

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF1-90X22-10

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF1-90X22-07

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF1-100X25-10

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : NBF1-100X25-15

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : OM2-50X10-05

Device Description : OptiFuse is a sterile bone graft composed of purified fibrillar Type I collagen OptiFuse is a sterile bone graft composed of purified fibrillar Type I collagen and Bi-Ostetic (60% hydroxyapatite - 40% tricalcium phosphate) resorbable granules. This device is safe and has excellent biocompatibility. After it is implanted, the graft resorbs and is later replaced by natural bone.OptiFuse is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. In weight bearing situations, the graft is to be used in conjunction with internal or external fixation devices. The fracture defect treated should not exceed 30 ml.

Device Class : 2

Duns Number: 081067703

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1