Catalog Number

014364

Brand Name

Cytrans Granules

Version/Model Number

10007520

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)

-

FDA Premarket Submission

K192597

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

0f2178b3-1402-40a9-b8f1-e5451a3587b3

Public Version Date

May 25, 2022

Public Version Number

2

DI Record Publish Date

April 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-