Arthrex®
- Primary DI
- 00888867106963
- Brand
- Arthrex®
- Company
- ARTHREX, INC.
- Model
- AR-513
- Catalog number
- AR-513
- Device description
- iBALANCE TKA X-RAY TEMPLATES
- Published
- 2018-06-14
- Public version status
- Update
- 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 |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00888867106963 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Suturing unit, single-use | A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device. |
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
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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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