Integra® - Integra® External Fixation SystemThe AO t-handle - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: Integra® External Fixation SystemThe AO t-handle is used in conjunction with the external Integra® External Fixation SystemThe AO t-handle is used in conjunction with the external fixation system.

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More Product Details

Catalog Number

5010001000

Brand Name

Integra®

Version/Model Number

5010001000

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

0d471d79-28a4-4366-bf31-7f5508bf5efe

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

August 30, 2017

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