TITAN™ - The Bow Tie Reamer Caddy contains non-cannulated - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: The Bow Tie Reamer Caddy contains non-cannulated bowtie reamers and cannulated bowtie rea The Bow Tie Reamer Caddy contains non-cannulated bowtie reamers and cannulated bowtie reamers to assist with the Fin-Lock glenoid.

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More Product Details

Catalog Number

-

Brand Name

TITAN™

Version/Model Number

TITANBOWTIEIMP

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

9136b79b-781c-4988-a165-be91ebdedf9c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2016

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