Catalog Number

OSNRM2530

Brand Name

SYMBIOS®

Version/Model Number

USOSNRM2530

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

96606089-fd5e-4e82-b0a4-425b53a89db8

Public Version Date

December 07, 2020

Public Version Number

4

DI Record Publish Date

June 24, 2017

Package DI Number

D716OSNRM25301

Quantity per Package

4

Contains DI Package

D716OSNRM25300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-