Glenoid IRI Handle - The Glenoid IRI Handle Body is a component of the - CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Duns Number:078667390

Device Description: The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly is indicated for use as part of the Glenoid Intelligent Reusable Instrument System (IRIS) in Total Shoulder Arthroplasty (TSA).

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More Product Details

Catalog Number

0006-0001

Brand Name

Glenoid IRI Handle

Version/Model Number

M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Record Status

Public Device Record Key

4482cfde-7b59-4757-8ac7-360f68a3bb5d

Public Version Date

April 06, 2020

Public Version Number

6

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CUSTOM ORTHOPAEDIC SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25