Catalog Number

970000104

Brand Name

SYMBIOS®

Version/Model Number

970000104

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

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

-

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

923fce76-7016-4726-8d50-9298fa286baa

Public Version Date

July 02, 2018

Public Version Number

3

DI Record Publish Date

June 30, 2017

Package DI Number

EFRI9700001042

Quantity per Package

4

Contains DI Package

EFRI9700001041

Package Discontinue Date

June 29, 2018

Package Status

Not in Commercial Distribution

Package Type

-