Duns Number:131747628
Device Description: VISCOUS-GEL APLICTR W/10CM MIXING TIP
Catalog Number
ABS-10050
Brand Name
Arthrex®
Version/Model Number
ABS-10050
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 08, 2020
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
KYZ
Product Code Name
SYRINGE, IRRIGATING (NON DENTAL)
Public Device Record Key
84da576c-5668-4ac8-ad55-d35296b3cb5c
Public Version Date
September 10, 2020
Public Version Number
6
DI Record Publish Date
February 15, 2017
Package DI Number
10888867001968
Quantity per Package
5
Contains DI Package
00888867001961
Package Discontinue Date
September 08, 2020
Package Status
Not 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 | 6506 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3411 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 2 |