Duns Number:071595540
Device Description: 10K ARTHROSCOPY INFLOW/OUTFLOW TUBE SET, QTY 10
Catalog Number
10K150
Brand Name
10K
Version/Model Number
10K150
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"
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
-
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
141e6e2b-9ee0-4330-85a9-4692751d2936
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20845854041212
Quantity per Package
10
Contains DI Package
10845854041215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
POUCH
| 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 |