DEVICE: Glenoid IRIS Surgical Tray (00811813020020)

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Device Record History
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Device Identifier (DI) Information
Glenoid IRIS Surgical Tray
E
Not in Commercial Distribution
0006-0011
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
00811813020020
GS1
June 21, 2019
1
078667390 *Terms of Use
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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Device Characteristics
MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
12143 Instrument tray, reusable
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PHX Shoulder Prosthesis, Reverse Configuration
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry, dark, cool place.
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Clinically Relevant Size

[?]
Size Type Text
Width: 8.537 Inch
Length: 20 Inch
Height: 3.9 Inch
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Device Record Status
653a8cbc-b2e6-41ea-8751-5bbbd90c08df
March 12, 2024
11
September 02, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
2168005905
info@customorthopaedics.com
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