Duns Number:144796497
Device Description: NATRELLE INSPIRA Rester Szr Sty MSZ-L380 Low
Catalog Number
MSZ-L380
Brand Name
Natrelle INSPIRA Resterilizable Sizers
Version/Model Number
MSZ-L380
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
-
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
K831566
Product Code
MRD
Product Code Name
Mammary Sizer
Public Device Record Key
3390fcd0-b589-457d-9c64-d8bf8865ed21
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
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 |