Blunt K-Wire - INTERVENTIONAL SPINE, INC

Duns Number:017663522

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More Product Details

Catalog Number

6203-00

Brand Name

Blunt K-Wire

Version/Model Number

6203-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 23, 2016

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

HXI

Product Code Name

Passer, Wire, Orthopedic

Device Record Status

Public Device Record Key

6c9cf320-f1ac-4020-bb84-7c20ff9a56ea

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTERVENTIONAL SPINE, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 150
2 A medical device with a moderate to high risk that requires special controls. 132
U Unclassified 13