Duns Number:829616478
Device Description: STERILE MINERVA Disposable HandpieceContents:(1) One Single use STERILE Minerva ES Disposa STERILE MINERVA Disposable HandpieceContents:(1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe(1) One Single Use STERILE 8mm Hegar Dilator(1) One Single use NON-STERILE Desiccant(1) One NON-STERILE Handpiece Instructions For Use(1) One NON-STERILE Dilator Instructions For Use
Catalog Number
MIN9770
Brand Name
Minerva Single Sterile Disposable Handpiece
Version/Model Number
MIN9770
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
P140013,P140013,P140013,P140013
Product Code
MNB
Product Code Name
Device, Thermal Ablation, Endometrial
Public Device Record Key
624596b2-b2d6-44c1-a98d-e6897c7fd730
Public Version Date
January 21, 2022
Public Version Number
9
DI Record Publish Date
June 27, 2017
Package DI Number
00862393000117
Quantity per Package
3
Contains DI Package
00862393000162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 4 |