Catalog Number

900000104

Brand Name

SYMBIOS®

Version/Model Number

900000104

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 04, 2022

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)

-

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

1badd1b8-3787-4475-8c75-af7143830838

Public Version Date

April 05, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2017

Package DI Number

EFRI9000001042

Quantity per Package

4

Contains DI Package

EFRI9000001041

Package Discontinue Date

April 03, 2022

Package Status

Not in Commercial Distribution

Package Type

-