Bio V BP Bioactive Glass with DBM Putty - Synthetic bone void filler containing DBM for - AMEND SURGICAL, INC.

Duns Number:080131031

Device Description: Synthetic bone void filler containing DBM for orthopedic applications, provided in a syrin Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser

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More Product Details

Catalog Number

BGP001-01

Brand Name

Bio V BP Bioactive Glass with DBM Putty

Version/Model Number

BGP001-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

Yes

FDA Premarket Submission

K142104

Product Code Details

Product Code

MBP

Product Code Name

Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Device Record Status

Public Device Record Key

b2bc7ad9-c6e4-408b-9e9a-26a3736a80f9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMEND SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10