Duns Number:679894738
Device Description: Yellow Needle Counter, Foam Block/Magnet, Blade Remover Feature, 20CT, 40CP_Non-sterilize Yellow Needle Counter, Foam Block/Magnet, Blade Remover Feature, 20CT, 40CP_Non-sterilize_100ea/cs
Catalog Number
-
Brand Name
ArcRoyal
Version/Model Number
Model 10-519001
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
-
Product Code
GAB
Product Code Name
NEEDLE, SUTURING, DISPOSABLE
Public Device Record Key
8eb61f94-b319-456e-adc7-0acf6e5ac7eb
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 27, 2021
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 | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 295 |