Duns Number:315304071
Device Description: ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM for MORCESCOPE, for morcellation following laser p ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM for MORCESCOPE, for morcellation following laser prostate enucleation, sterile
Catalog Number
49700113
Brand Name
PIRANHA
Version/Model Number
49700113
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 29, 2017
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
FJK
Product Code Name
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Public Device Record Key
81182208-b99e-41ca-9efe-167f92e75283
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
June 28, 2017
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 |