Catalog Number

-

Brand Name

NEURAY ®

Version/Model Number

8004005

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

b4ff08db-9110-4fb8-92a0-8686a2d21aa4

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2018

Package DI Number

20643169932030

Quantity per Package

200

Contains DI Package

00643169932036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK