| Primary Device ID | 00811813020006 |
| NIH Device Record Key | 4482cfde-7b59-4757-8ac7-360f68a3bb5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glenoid IRI Handle |
| Version Model Number | M |
| Catalog Number | 0006-0001 |
| Company DUNS | 078667390 |
| Company Name | CUSTOM ORTHOPAEDIC SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811813020006 [Primary] |
| PHX | Shoulder Prosthesis, Reverse Configuration |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
[00811813020006]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2016-09-02 |
| 00811813020525 - VisionAir 3D Stent | 2024-03-19 Patient-Specific Silicone Airway Stent |
| 00811813020020 - Glenoid IRIS Surgical Tray | 2019-08-09 The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRI |
| 00811813020235 - SmartBone | 2019-02-07 The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at |
| 00811813020006 - Glenoid IRI Handle | 2018-10-08The 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). |
| 00811813020006 - Glenoid IRI Handle | 2018-10-08 The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assem |
| 00811813020013 - Glenoid IRI Barrel | 2018-10-08 The Glenoid IRI Barrel is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly i |
| 00811813020037 - Glenoid IRI Cap | 2018-10-08 The Glenoid IRI Cap is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly is i |
| 00811813020044 - Glenoid IRI Leg (10mm) | 2018-10-08 The Glenoid IRI Leg (10mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (10mm) is i |
| 00811813020051 - Glenoid IRI Leg (11mm) | 2018-10-08 The Glenoid IRI Leg (11mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (11mm) is i |