Duns Number:428898555
Device Description: INTRODUCER NEEDLE 75MM PER AGO 14G
Catalog Number
IN 14075N
Brand Name
INTRODUCER NEEDLE
Version/Model Number
INTRODUCER NEEDLE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
725a6fb2-6e39-49f9-a089-8fec7dd3f85d
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
December 18, 2019
Package DI Number
48033055141206
Quantity per Package
20
Contains DI Package
08033055141208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 79 |