Duns Number:486711679
Device Description: RIA TUBE ASSEMBLY MIN 360MM LENGTH-STERILE FOR 314.742
Catalog Number
314745S
Brand Name
NA
Version/Model Number
314.745S
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
K013527,K111437,K042899
Product Code
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
6f74d194-dcfc-46e5-93b8-3226013ef1ed
Public Version Date
April 29, 2022
Public Version Number
6
DI Record Publish Date
June 30, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |