Duns Number:002112626
Device Description: Silicone Silo Bag For The Reduction of Abdominal Ventral Wall Defects
Catalog Number
SSB55
Brand Name
Silicone Silo Bag
Version/Model Number
SSB55
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
5242fce5-04bf-49b0-b890-388dbd15b57b
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
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 436 |