Duns Number:068109169
Device Description: 3mm 30º Arthroscope
Catalog Number
AS-175S
Brand Name
Q System Arthroscope
Version/Model Number
AS-175S
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
K133018
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
138751ee-efbb-4a53-bd16-5f9032d52643
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 14, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 117 |