Duns Number:010209877
Device Description: Silicone Gel Breast Implant, Textured Round, Xtra High Projection, 445 cc
Catalog Number
20621-445XP
Brand Name
OPUS Silicone Gel Breast Implant
Version/Model Number
20621-445XP
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
P070004
Product Code
FTR
Product Code Name
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Public Device Record Key
965bea28-a69f-4a73-8170-903abdffc07e
Public Version Date
May 23, 2019
Public Version Number
1
DI Record Publish Date
May 15, 2019
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 58 |
| 3 | A medical device with high risk that requires premarket approval | 549 |
| U | Unclassified | 312 |