Catalog Number

-

Brand Name

Sorrento Bone Graft Substitute Strip (10cc)

Version/Model Number

HB-116-0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

43dc86f3-c292-4e3d-a644-ddf3e1dc01ef

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-