Duns Number:015510540
Device Description: 1.9/2.0 Fr, 30ga Modified Seldinger Introductor Kit
Catalog Number
1958-004
Brand Name
NeoMagic
Version/Model Number
1958-004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K951384,K951384
Product Code
KZH
Product Code Name
Introducer, Syringe Needle
Public Device Record Key
a02963f3-4477-48c2-9467-184746e23d6a
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
B33919580045
Quantity per Package
10
Contains DI Package
B33919580040
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |