Glenoid IRIS Surgical Tray 0006-0011

GUDID 00811813020020

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]

CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

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Primary Device ID	00811813020020
NIH Device Record Key	653a8cbc-b2e6-41ea-8751-5bbbd90c08df
Commercial Distribution Status	In Commercial Distribution
Brand Name	Glenoid IRIS Surgical Tray
Version Model Number	E
Catalog Number	0006-0011
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
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

Customer Support Contacts

Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com
Phone	2168005905
Email	info@customorthopaedics.com

Device Dimensions

Height	3.9 Inch
Height	3.9 Inch
Height	3.9 Inch
Height	3.9 Inch
Height	3.9 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch
Width	8.537 Inch
Length	20 Inch
Height	3.9 Inch

Operating and Storage Conditions

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.
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 Identifiers

Device Issuing Agency	Device ID
GS1	00811813020020 [Primary]

FDA Product Code

PHX	Shoulder Prosthesis, Reverse Configuration