Catalog Number

-

Brand Name

Neuray®

Version/Model Number

8004055

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

K923027,K923027

Product Code

HBA

Product Code Name

NEUROSURGICAL PADDIE

Public Device Record Key

9b0575c6-be62-4297-905b-1a4d06dc21c9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20681490171667

Quantity per Package

200

Contains DI Package

00681490171663

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK