Duns Number:853166098
Device Description: Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant MatrixRound Sizer Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant MatrixRound Sizer - Demi 360 cc
Catalog Number
SZD-360
Brand Name
Motiva Implant Matrix
Version/Model Number
SZD-360
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MRD
Product Code Name
Sizer, Mammary, Breast Implant Volume
Public Device Record Key
72a2a49b-9ca0-4d9a-baff-967a81230a8b
Public Version Date
November 02, 2021
Public Version Number
1
DI Record Publish Date
October 25, 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 |
---|---|---|
U | Unclassified | 80 |