Duns Number:071595540
Device Description: MENISCECTOMY ELECTRODE, STANDARD DESIGN (ELECTRODE ONLY), QTY 5
Catalog Number
C5010A
Brand Name
NA
Version/Model Number
C5010A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K823424,K823424,K823424
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
8aa8edef-9b5d-4191-b05c-1b0340f519b2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10845854017920
Quantity per Package
5
Contains DI Package
20845854017927
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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |