Integra® External Fixation System - External Fixation System - Instruments, - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: External Fixation System - Instruments, Provisional Supports

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More Product Details

Catalog Number

XFIX3INSTP

Brand Name

Integra® External Fixation System

Version/Model Number

XFIX3INSTP

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

HXC

Product Code Name

WRENCH

Device Record Status

Public Device Record Key

cfb558ef-0393-4f1b-9392-8cec5dba473c

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

April 13, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASCENSION ORTHOPEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1909
2 A medical device with a moderate to high risk that requires special controls. 1404
3 A medical device with high risk that requires premarket approval 12
U Unclassified 15