Dark Star - Pre-bent Rod - REPUBLIC SPINE

Duns Number:061891717

Device Description: Pre-bent Rod

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More Product Details

Catalog Number

DS-1120

Brand Name

Dark Star

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2016

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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

bc987706-224b-4002-952c-ed476ee78a48

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REPUBLIC SPINE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 261