Duns Number:167450993
Device Description: Smooth, Ultra High Profile, Suture Tabs, Integral Injection Dome, 455cc
Catalog Number
SMXP110RUH
Brand Name
ARTOURA Breast Tissue Expander
Version/Model Number
SMXP110RUH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
K161176
Product Code
LCJ
Product Code Name
EXPANDER, SKIN, INFLATABLE
Public Device Record Key
9fb356d1-e0a0-4416-9fac-aa10e9030141
Public Version Date
September 23, 2019
Public Version Number
4
DI Record Publish Date
July 01, 2016
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |
| 3 | A medical device with high risk that requires premarket approval | 545 |
| U | Unclassified | 514 |