Catalog Number

914-10

Brand Name

NeoMagic

Version/Model Number

914-10

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

aa379e1f-efa3-4c36-96d0-ff7b774d99ca

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

B339914105

Quantity per Package

5

Contains DI Package

B339914100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case