Duns Number:131747628
Device Description: SCHOTT syriQ STERILE 3 ML SYRINGE
Catalog Number
82197-0721-16
Brand Name
Arthrex®
Version/Model Number
82197-0721-16
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
P170016
Product Code
MOZ
Product Code Name
Acid, hyaluronic, intraarticular
Public Device Record Key
a8c18668-a655-4385-ba51-40f1dff15d1a
Public Version Date
February 09, 2022
Public Version Number
1
DI Record Publish Date
February 01, 2022
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 | 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 |