Catalog Number

OSCRM1520

Brand Name

SYMBIOS®

Version/Model Number

USOSCRM1520

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

NPL

Product Code Name

Barrier, animal source, intraoral

Public Device Record Key

68402437-b41d-4f9e-b44d-e8d6c66f0b5a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 24, 2017

Package DI Number

D716OSCRM15201

Quantity per Package

2

Contains DI Package

D716OSCRM15200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-