Arthrex®
- Primary DI
- 00888867276123
- Brand
- Arthrex®
- Company
- ARTHREX, INC.
- Model
- AR-9301-39CPC
- Catalog number
- AR-9301-39CPC
- Device description
- ECLIPSE TRUNION 39MM, SLOTTED, TPS CaP
- Published
- 2021-05-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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 |
|---|
| 00888867276123 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Coated shoulder humeral stem prosthesis | A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. |
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
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00888867060050 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
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| 00888867060081 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
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| 00888867060104 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867060111 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867139510 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867139541 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867276130 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |
| 00888867276147 | Arthrex® | ARTHREX, INC. | QHQ | 2021-05-26 |