Duns Number:315304071
Device Description: CUTTING TUBE Ø 12MM PACK=1 PC, WL 200mm, for use with handpiece 8307011, for fragmentatio CUTTING TUBE Ø 12MM PACK=1 PC, WL 200mm, for use with handpiece 8307011, for fragmentation of tissue, in gynecology, reusable
Catalog Number
8307012
Brand Name
MORCE POWER PLUS
Version/Model Number
8307012
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
-
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
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
2eeabbf2-de23-4588-bd0b-fe71ed6b2328
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |