Duns Number:167450993
Device Description: TH Tall Height, High Profile 680cc Textured Contour Silicone
Catalog Number
334-1404
Brand Name
MENTOR MemoryShape Breast Implant
Version/Model Number
3341404
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
P060028
Product Code
FTR
Product Code Name
Prosthesis, breast, noninflatable, internal, silicone gel-filled
Public Device Record Key
9cb8af77-22d5-4973-987e-3ae942ffafd0
Public Version Date
February 11, 2021
Public Version Number
3
DI Record Publish Date
February 28, 2018
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 |