Duns Number:167450993
Device Description: Post-Operatively Adjustable Saline Breast Implant, 325cc
Catalog Number
354-2450M
Brand Name
MENTOR SILTEX Round SPECTRUM
Version/Model Number
3542450M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 10, 2021
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"
-
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
P990075
Product Code
FWM
Product Code Name
Prosthesis, breast, inflatable, internal, saline
Public Device Record Key
235d1d77-0567-4643-accf-f483bd6e2d09
Public Version Date
February 11, 2021
Public Version Number
5
DI Record Publish Date
September 17, 2014
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 |