Catalog Number
RHUB50
Brand Name
N/A
Version/Model Number
RHUB50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 06, 2018
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
-
Product Code
GAA
Product Code Name
NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
Public Device Record Key
e11d4c87-08d0-44be-96ab-0169b0b12e99
Public Version Date
January 08, 2021
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036011785
Quantity per Package
750
Contains DI Package
20705036011788
Package Discontinue Date
February 06, 2018
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| 3 | A medical device with high risk that requires premarket approval | 2 |