Glenoid IRIS Surgical Tray - The Glenoid Intelligent Reusable Instrument - CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Duns Number:078667390

Device Description: The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that c The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRIS devices. All of the Arthrex Glenoid (IRIS) devices are indicated for steam sterilization in this surgical tray. The following are contained in the tray:Glenoid IRI Barrel (DI: 00811813020013) [Q.1]Glenoid IRI Handle (DI: 00811813020006) [Q.1]Glenoid IRI Collet/Cap (DI: 00811813020037) [Q.1]Glenoid IRI Leg - 10mm (DI: 00811813020044) [Q.1]Glenoid IRI Leg - 12mm (DI: 00811813020068) [Q.1]Glenoid IRI Leg - 11mm (DI: 00811813020051) [Q.1]Glenoid IRI Leg - 13mm (DI: 00811813020075) [Q.1]Glenoid IRI Leg - 14mm (DI: 00811813020082) [Q.1]Glenoid IRI Leg - 15mm (DI: 00811813020099) [Q.2]Glenoid IRI Leg - 16mm (DI: 00811813020105) [Q.2]Glenoid IRI Leg - 17mm (DI: 00811813020112) [Q.2]Glenoid IRI Leg - 18mm (DI: 00811813020129) [Q.2]Glenoid IRI Leg - 19mm (DI: 00811813020136) [Q.2]Glenoid IRI Leg - 20mm (DI: 00811813020143) [Q.2]Glenoid IRI Leg - 21mm (DI: 00811813020150) [Q.2]Glenoid IRI Leg - 22mm (DI: 00811813020167) [Q.2]Glenoid IRI Leg - 23mm (DI: 00811813020174) [Q.2]Glenoid IRI Leg - 24mm (DI: 00811813020181) [Q.2]Glenoid IRI Leg - 25mm (DI: 00811813020198) [Q.2]SmartBase Core (DI: 00811813020297) [Q.1]SmartBase Center Pillar (DI: 00811813020303) [Q.1]SmartBase Ruler (DI: 00811813020280) [Q.5]SmartBase Screws (DI: 00811813020334) [Q.5]SmartBone Mount (DI: 00811813020204) [Q.1]Optional: SmartBone (DI: 00811813020235) [Q.1]

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More Product Details

Catalog Number

0006-0011

Brand Name

Glenoid IRIS Surgical Tray

Version/Model Number

E

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

653a8cbc-b2e6-41ea-8751-5bbbd90c08df

Public Version Date

September 16, 2022

Public Version Number

10

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