Catalog Number

SSB-SR-08

Brand Name

Silicone Silo Bag with Wire Ring Sizer Ring

Version/Model Number

SSB-SR-08

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"

Yes

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

K973082

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

aa041326-9093-4e28-8f08-e66ebd9a350f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-