Catalog Number

OSTRNRM1220

Brand Name

SYMBIOS®

Version/Model Number

USOSTRNRM1220

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

-

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

cdc1ec6c-81db-4900-8f90-d0fea9e2a669

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

June 24, 2017

Package DI Number

D716OSTRNRM12201

Quantity per Package

4

Contains DI Package

D716OSTRNRM12200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-