Arthrex®
- Primary DI
- 00888867276086
- Brand
- Arthrex®
- Company
- ARTHREX, INC.
- Model
- AR-9437-16
- Catalog number
- AR-9437-16
- Device description
- ARTHREX ECLIPSE™ TRIAL HEAD, 37/16
- Published
- 2022-07-15
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QHQ | Total shoulder arthroplasty system |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QHQ | Total Shoulder Arthroplasty System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888867276086 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Shoulder reverse/standard adaptor prosthesis trial | A copy of a final shoulder reverse/standard adaptor prosthesis designed to be used before revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is double male taper disc typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(800)934-4404 | complaints@arthrex.com |
Regulatory Flags
- DUNS number
- 131747628
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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|---|
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| 00888867139510 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867139541 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867276123 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867276130 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867276147 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |