FDA.reportPublic FDA data

Glenoid IRIS Surgical Tray

Primary DI
00811813020020
Brand
Glenoid IRIS Surgical Tray
Company
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
Model
E
Catalog number
0006-0011
Device description
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]
Published
2016-09-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811813020020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811813020020008118130200208118130200200811813020020

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.9Inch
Length20Inch
Width8.537Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2168005905info@customorthopaedics.com

Regulatory Flags#

DUNS number
078667390
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811813020525VisionAir 3D Stent0010-01262024-03-11
00811813020006Glenoid IRI HandleM0006-00012016-09-02
00811813020013Glenoid IRI BarrelM0006-00022016-09-02
00811813020037Glenoid IRI CapJ0006-00032016-09-02
00811813020044Glenoid IRI Leg (10mm)L0006-0005-102016-09-02
00811813020051Glenoid IRI Leg (11mm)L0006-0005-112016-09-02
00811813020068Glenoid IRI Leg (12mm)L0006-0005-122016-09-02
00811813020075Glenoid IRI Leg (13mm)L0006-0005-132016-09-02
00811813020082Glenoid IRI Leg (14mm)L0006-0005-142016-09-02
00811813020099Glenoid IRI Leg (15mm)L0006-0005-152016-09-02
00811813020105Glenoid IRI Leg (16mm)L0006-0005-162016-09-02
00811813020112Glenoid IRI Leg (17mm)L0006-0005-172016-09-02
00811813020129Glenoid IRI Leg (18mm)L0006-0005-182016-09-02
00811813020136Glenoid IRI Leg (19mm)L0006-0005-192016-09-02
00811813020143Glenoid IRI Leg (20mm)L0006-0005-202016-09-02
00811813020150Glenoid IRI Leg (21mm)L0006-0005-212016-09-02
00811813020167Glenoid IRI Leg (22mm)L0006-0005-222016-09-02
00811813020174Glenoid IRI Leg (23mm)L0006-0005-232016-09-02
00811813020181Glenoid IRI Leg (24mm)L0006-0005-242016-09-02
00811813020198Glenoid IRI Leg (25 mm)L0006-0005-252016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B1132N2HN200460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
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B1132N2HN200520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210500Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN210560Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
07630699705950Shoulder SystemMedacta International SAPHX2026-10-01
07630699705967Shoulder SystemMedacta International SAPHX2026-10-01