Duns Number:010209877
Device Description: Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 505 cc
Catalog Number
GS10621-505MP
Brand Name
OPUS Silicone Gel Breast Implant Sizer
Version/Model Number
GS10621-505MP
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
K200706
Product Code
MRD
Product Code Name
Sizer, Mammary, Breast Implant Volume
Public Device Record Key
e2caf129-5f2a-42bb-9489-2e3d4267ebfe
Public Version Date
January 19, 2021
Public Version Number
1
DI Record Publish Date
January 11, 2021
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 |