Duns Number:078667390
Device Description: The Glenoid Intelligent Reusable Instrument System (IRIS) Surgical Tray is the tray that c 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]
Catalog Number
0006-0011
Brand Name
Glenoid IRIS Surgical Tray
Version/Model Number
E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KWS
Product Code Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Public Device Record Key
653a8cbc-b2e6-41ea-8751-5bbbd90c08df
Public Version Date
September 16, 2022
Public Version Number
10
DI Record Publish Date
September 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |