Catalog Number

-

Brand Name

Neuray®

Version/Model Number

8004051

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2020

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

K923027,K923027

Product Code

HBA

Product Code Name

NEUROSURGICAL PADDIE

Public Device Record Key

f61de562-b4f1-44fe-b480-de161c9878a0

Public Version Date

November 01, 2021

Public Version Number

2

DI Record Publish Date

March 23, 2019

Package DI Number

20763000032887

Quantity per Package

200

Contains DI Package

00763000032883

Package Discontinue Date

February 05, 2020

Package Status

Not in Commercial Distribution

Package Type

PK