Catalog Number

ALL

Brand Name

Spetzler - OMT

Version/Model Number

Neuro Patties

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020736,K020736,K020736,K020736,K020736,K020736,K020736,K020736,K020736,K020736

Product Code

HBA

Product Code Name

Neurosurgical Paddie

Public Device Record Key

1a46fd0a-f258-4dbc-97e5-3fd6dc993291

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 24, 2017

Package DI Number

M7311100149

Quantity per Package

3

Contains DI Package

M731100020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box