Tempus™ - Plate Bender - NEUROSTRUCTURES, INC

Duns Number:079391677

Device Description: Plate Bender

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More Product Details

Catalog Number

-

Brand Name

Tempus™

Version/Model Number

10-90-027

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

-

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

52a675a1-04ac-4ea7-b9e6-083730ff364f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUROSTRUCTURES, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 699