Glenoid IRI Leg (15mm) 0006-0005-15

GUDID 00811813020099

The Glenoid IRI Leg (15mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (15mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).

CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

Orthopaedic implant/instrument assembling device
Primary Device ID00811813020099
NIH Device Record Key1ec170e2-fd56-47f8-ab06-ff7b8c136c5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlenoid IRI Leg (15mm)
Version Model NumberL
Catalog Number0006-0005-15
Company DUNS078667390
Company NameCUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com
Phone2168005905
Emailinfo@customorthopaedics.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100811813020099 [Primary]

FDA Product Code

PHXShoulder Prosthesis, Reverse Configuration

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


[00811813020099]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-08
Device Publish Date2016-09-02

Devices Manufactured by CUSTOM ORTHOPAEDIC SOLUTIONS, INC.

00811813020525 - VisionAir 3D Stent2024-03-19 Patient-Specific Silicone Airway Stent
00811813020020 - Glenoid IRIS Surgical Tray2019-08-09 The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that contains all of the Arthrex Glenoid IRI
00811813020235 - SmartBone2019-02-07 The SmartBone is a 3D-printed, patient-specific device that is used to set the Glenoid Intelligent Reusable Instrument (IRI) at
00811813020006 - Glenoid IRI Handle2018-10-08 The Glenoid IRI Handle Body is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assem
00811813020013 - Glenoid IRI Barrel2018-10-08 The Glenoid IRI Barrel is a component of the Glenoid Intelligent Reusable Instrument (IRI) Assembly. The Glenoid IRI Assembly i
00811813020037 - Glenoid IRI Cap2018-10-08 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

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