Arthrex
- Primary DI
- B504SWAR89140
- Brand
- Arthrex
- Company
- Provision
- Model
- AR-8914
- Published
- 2023-05-18
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| HXI | Passer, Wire, Orthopedic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HXI | Passer, Wire, Orthopedic | Orthopedic | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B504SWAR89140 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Suturing unit, reprocessed | 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 may also knot, cut and/or tighten the sutures/ligature loop during or after placement. 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. This is a previously used single-use device that has been processed for an additional single-use patient application. |
Regulatory Flags
- DUNS number
- 016889401
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10810128462645 | Nitinol Loop Passer MEDACTA | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | HXI | 2026-02-09 |
| 00841731134769 | Hintermann Series | VILEX LLC | HXI | 2026-01-16 |
| 06974940306369 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-12 |
| 06974940306147 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306154 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306161 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306178 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306185 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306192 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306208 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306215 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306222 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306239 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306246 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306253 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 06974940306260 | endophix | Suzhou Endophix Co., Ltd. | HXI | 2025-12-05 |
| 00889795154033 | Special Instrument | Paragon 28, Inc. | HXI | 2025-11-14 |
| 00889795154040 | Special Instrument | Paragon 28, Inc. | HXI | 2025-11-14 |
| 00889795154057 | Special Instrument | Paragon 28, Inc. | HXI | 2025-11-14 |
| 00889795154064 | Special Instrument | Paragon 28, Inc. | HXI | 2025-11-14 |
| 03662663086271 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663087834 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093262 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093378 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093385 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093392 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093408 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093453 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093712 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
| 03662663093729 | LineSider | Highridge Medical, LLC | HXI | 2025-10-03 |
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