Duns Number:010209877
Device Description: Silicone Gel Breast Implant, Smooth Round, Moderate High Profile, 695 cc
Catalog Number
10521-695HP
Brand Name
SIENTRA Silicone Gel Breast Implant
Version/Model Number
10521-695HP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2022
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"
-
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
61ca7cb3-c0c3-417d-96ab-8cccbce5f418
Public Version Date
June 13, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
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 |