Duns Number:058614483
Device Description: Arterial Needle,Ultra Thin Wall with Echogenic Tip,19 G (1.067 mm) x 2.75"" (70 mm)
Catalog Number
AN-19GE
Brand Name
ClosureFast
Version/Model Number
AN-19GE
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
-
Product Code
GDF
Product Code Name
GUIDE, NEEDLE, SURGICAL
Public Device Record Key
24ddf881-c3ae-4a34-afee-b8233d3771b6
Public Version Date
November 13, 2018
Public Version Number
1
DI Record Publish Date
October 13, 2018
Package DI Number
20884521140186
Quantity per Package
50
Contains DI Package
10884521140189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |