Duns Number:167450993
Device Description: Smooth Moderate High Profile Xtra, 400 cc Smooth Round Silicone
Catalog Number
SMHX-400
Brand Name
MENTOR MemoryGel Xtra Breast Implant
Version/Model Number
SMHX400
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
-
Product Code
FTR
Product Code Name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Public Device Record Key
b27c71cc-c7e7-40ae-a853-177bea7228e0
Public Version Date
August 16, 2022
Public Version Number
3
DI Record Publish Date
January 29, 2021
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 |