Duns Number:010209877
Device Description: Tissue Expander, Round, 3-Valves, Smooth, 100 ml
Catalog Number
800-100U3
Brand Name
SIENTRA Tissue Expander
Version/Model Number
800-100U3
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2022
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K981852
Product Code
LCJ
Product Code Name
Expander, Skin, Inflatable
Public Device Record Key
0105300b-a914-4a8d-b516-ea2d42912bc8
Public Version Date
June 13, 2022
Public Version Number
5
DI Record Publish Date
October 23, 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 | 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 |