Stage 1 Distractor - INTERVENTIONAL SPINE, INC

Duns Number:017663522

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

6205-00

Brand Name

Stage 1 Distractor

Version/Model Number

6205-00

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

11e662e0-2105-4136-a24f-ccb397418794

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