Duns Number:316305242
Catalog Number
-
Brand Name
Tube set for irrigation, single-use
Version/Model Number
VP150-10
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
K062380,K062380
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
f39ef752-da0e-4788-90b2-c635cb026ba9
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
August 19, 2016
Package DI Number
04056702002770
Quantity per Package
10
Contains DI Package
04056702002763
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |