Duns Number:140727624
Device Description: AMC/4 Arterial Needle–21ga x 1” (2.5cm)
Catalog Number
195322
Brand Name
Arterial Needle
Version/Model Number
195322
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
b7018235-bfad-4657-95ae-078ff7235631
Public Version Date
July 07, 2022
Public Version Number
1
DI Record Publish Date
June 29, 2022
Package DI Number
10886333208446
Quantity per Package
10
Contains DI Package
00886333208449
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |