Duns Number:167450993
Device Description: Tall Height, High Profile, TH 485cc Gel Sizer
Catalog Number
RSZ-4125S
Brand Name
MENTOR MemoryShape Resterilizable Gel Sizer
Version/Model Number
RSZ4125S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
For Single-Use
-
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
K151055
Product Code
MRD
Product Code Name
SIZER, MAMMARY, BREAST IMPLANT VOLUME
Public Device Record Key
11d4e8fb-2492-427c-b86d-0ad554de8ab0
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
February 28, 2018
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 |