Duns Number:002112626
Device Description: Softspan™ Tissue Expander, VU Angle, Integrated Precision Point™ Magnetic Injection Port S Softspan™ Tissue Expander, VU Angle, Integrated Precision Point™ Magnetic Injection Port System, ZoneTextured Surface, Reinforced Base
Catalog Number
VU-ATE-200
Brand Name
Softspan™ Tissue Expander
Version/Model Number
VU-ATE-200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 11, 2016
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
-
Product Code
LCJ
Product Code Name
Expander, Skin, Inflatable
Public Device Record Key
0b3eb2c0-de6c-48d8-bdb6-d9632abeea24
Public Version Date
September 23, 2019
Public Version Number
4
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 |