Sniper® Spine System - Cannulated Pedicle Screw Reduction Tab 9.5 mm x - Spine Wave, Inc.

Duns Number:067789763

Device Description: Cannulated Pedicle Screw Reduction Tab 9.5 mm x 45 mm

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More Product Details

Catalog Number

11-4324

Brand Name

Sniper® Spine System

Version/Model Number

11-4324

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

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

-

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Device Record Status

Public Device Record Key

2057536d-4ce2-4147-9dcc-c5ef3c9daa91

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINE WAVE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3264