Catalog Number

10101-S

Brand Name

Bi-Portal Bone Graft Delivery Device

Version/Model Number

10101-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

FDA Premarket Submission

K142661

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

7321e8fc-1844-491d-a425-92b8507a9725

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

December 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-