C-Graft Putty - Hans Biomed Corp.

Duns Number:689512625

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More Product Details

Catalog Number

-

Brand Name

C-Graft Putty

Version/Model Number

CG-P10

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

-

Product Code Details

Product Code

NUN

Product Code Name

Bone Grafting Material, Human Source

Device Record Status

Public Device Record Key

a4f083b5-761e-4552-972b-9a2e70672c14

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANS BIOMED CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 147