Catalog Number

-

Brand Name

Neuray®

Version/Model Number

8004000

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

9ce7d5b9-e65e-4711-9eb2-9c4dc76387c7

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 17, 2019

Package DI Number

20763000032788

Quantity per Package

200

Contains DI Package

00763000032784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK