M6-C - Trial Handle, G6 - Spinal Kinetics, Inc.

Duns Number:171513125

Device Description: Trial Handle, G6

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More Product Details

Catalog Number

CIH-100-06

Brand Name

M6-C

Version/Model Number

FA 0191

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

776716a9-674a-4786-85de-d92bdd3214d6

Public Version Date

October 19, 2020

Public Version Number

2

DI Record Publish Date

March 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINAL KINETICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 32
3 A medical device with high risk that requires premarket approval 11