Duns Number:144796497
Device Description: NATRELLE Style 68MP-420 Moderate Projection smooth round saline
Catalog Number
68-420
Brand Name
NATRELLE Saline-Filled Breast Implants
Version/Model Number
68-420
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
P990074
Product Code
FWM
Product Code Name
Prosthesis, Breast, Inflatable, Internal, Saline
Public Device Record Key
6583e5f0-52d2-4445-a89e-57f6573e0960
Public Version Date
April 30, 2021
Public Version Number
4
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |
3 | A medical device with high risk that requires premarket approval | 982 |
U | Unclassified | 702 |