Catalog Number

-

Brand Name

A-graft®[Bone grafting material,Animal source]

Version/Model Number

HAS025SV

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

K151542

Product Code

NPM

Product Code Name

Bone Grafting Material, Animal Source

Public Device Record Key

55f32812-ae24-450c-8b91-dda2c1072f8b

Public Version Date

October 03, 2018

Public Version Number

3

DI Record Publish Date

April 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-