Duns Number:018925968
Catalog Number
10-401
Brand Name
MyoSure Tissue Removal Device
Version/Model Number
10-401
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"
-
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
K142029,K142029,K142029
Product Code
HIH
Product Code Name
HYSTEROSCOPE (AND ACCESSORIES)
Public Device Record Key
27c97822-fdfe-4b60-a231-e9708f780ba1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 08, 2016
Package DI Number
35420045504817
Quantity per Package
3
Contains DI Package
15420045504813
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 | 130 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 311 |
| 3 | A medical device with high risk that requires premarket approval | 96 |