Glenoid IRIS Surgical Tray
Basic Information
- Brand Name
- Glenoid IRIS Surgical Tray
- Primary DI
- 00811813020020
- Version / Model
- E
- Catalog Number
- 0006-0011
- Company Name
- CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
- Labeler DUNS
- 078667390
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 10
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 653a8cbc-b2e6-41ea-8751-5bbbd90c08df
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]
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | 888.3660 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811813020020 | GS1 |
Customer Contacts
- Phone
- 2168005905
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8.537 | Inch | |
| Length | 20 | Inch | |
| Height | 3.9 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dry, dark, cool place.