Duns Number:023904428
Device Description: Safety Hypodermic Needles 21G x 1 in (100/bx, 8/cs)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
102-N211S3
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"
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
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
8d9f5d56-22df-47fd-8795-f58efc1b6e10
Public Version Date
February 10, 2020
Public Version Number
2
DI Record Publish Date
November 19, 2019
Package DI Number
40612479246100
Quantity per Package
8
Contains DI Package
10612479246338
Package Discontinue Date
-
Package Status
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |