Duns Number:017663522
Device Description: Sterile Access Needle, 11GA x 15cm
Catalog Number
9046
Brand Name
Access Needle
Version/Model Number
9046
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 23, 2016
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
HXK
Product Code Name
Holder, Needle; Orthopedic
Public Device Record Key
df762ff9-2947-4e72-ba4e-4e851c6a0816
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2015
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 | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |
| U | Unclassified | 13 |