Leadpoint - Leadpoint Focus Notebook, US - NATUS MANUFACTURING LIMITED

Duns Number:896421240

Device Description: Leadpoint Focus Notebook, US

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More Product Details

Catalog Number

9033A0811AA

Brand Name

Leadpoint

Version/Model Number

9033A0811AA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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

K140680

Product Code Details

Product Code

GZL

Product Code Name

Electrode, Depth

Device Record Status

Public Device Record Key

f42b2dd2-49be-4ea4-922a-43b0650c7e28

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS MANUFACTURING LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 154