OIC External Fixation System - 11MM X 300MM CARBON BAR - ORTHOPAEDIC IMPLANT COMPANY, THE

Duns Number:070061160

Device Description: 11MM X 300MM CARBON BAR

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More Product Details

Catalog Number

-

Brand Name

OIC External Fixation System

Version/Model Number

XBR-11300

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

K171211

Product Code Details

Product Code

KTT

Product Code Name

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Device Record Status

Public Device Record Key

40cfd609-08cc-4492-b1fe-c66baef787d5

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOPAEDIC IMPLANT COMPANY, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1585