Catalog Number

-

Brand Name

Snap On Spherz

Version/Model Number

PM8001-7D

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022074

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

0fc32433-1a6e-428a-b059-702092a1f10b

Public Version Date

August 24, 2018

Public Version Number

1

DI Record Publish Date

July 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-