Duns Number:010209877
Device Description: Tissue Expander, Flat Oval, Smooth Surface, Remote Port, Reinforced Base, 75-188 cc
Catalog Number
SRE-FO-075S
Brand Name
Softspan Tissue Expander
Version/Model Number
SRE-FO-075S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K070303
Product Code
LCJ
Product Code Name
Expander, Skin, Inflatable
Public Device Record Key
43f54083-31d7-48aa-b794-3ee5fadcf1d0
Public Version Date
December 25, 2020
Public Version Number
1
DI Record Publish Date
December 17, 2020
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| 3 | A medical device with high risk that requires premarket approval | 549 |
| U | Unclassified | 312 |