Titan™ - Titan™ Reverse Shoulder SystemPeripheral Reamer - Ascension Orthopedics, Inc.

Duns Number:942377524

Device Description: Titan™ Reverse Shoulder SystemPeripheral Reamer Eccentric MODThe peripheral eccentric ream Titan™ Reverse Shoulder SystemPeripheral Reamer Eccentric MODThe peripheral eccentric reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.

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More Product Details

Catalog Number

RMR-0960-076-02

Brand Name

Titan™

Version/Model Number

RMR096007602

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

HTO

Product Code Name

REAMER

Device Record Status

Public Device Record Key

df5f1e25-c6be-4569-a932-cd84ea15886b

Public Version Date

November 06, 2020

Public Version Number

4

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