Duns Number:969752364
Device Description: Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for singl Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a component within the Eclipse PRP 22mL Patient Kit.
Catalog Number
-
Brand Name
Eclipse Hypodermic Needle - 18G
Version/Model Number
50PRP2500-N18gx25mm
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
K172938
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
a3209455-573d-4c61-a8d1-26c295b84338
Public Version Date
January 19, 2022
Public Version Number
1
DI Record Publish Date
January 11, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |