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

db20b837-2fbf-4518-a4a6-3ada00d9bba4

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 07, 2019

Package DI Number

20643169932139

Quantity per Package

200

Contains DI Package

00643169932135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK