Sonoma Orthopedic Products, Inc
- Primary DI
- 00816988011804
- Brand
- Sonoma Orthopedic Products, Inc
- Company
- SONOMA ORTHOPEDIC PRODUCTS, INC.
- Model
- Guidewire Inserter
- Catalog number
- IN6310
- Published
- 2015-08-19
- 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 |
|---|---|
| LXH | Orthopedic Manual Surgical Instrument |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00816988011804 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816988011804 | 00816988011804 | 816988011804 | 0816988011804 |
GMDN Terms#
| Term | Definition |
|---|---|
| General-purpose non-vascular guidewire | A non-dedicated metal wire designed to position a catheter or similar interventional device (e.g., a dilator or an endoscope) within a lumen of the gastrointestinal (GI) tract, the tracheobronchial tree, and the urinary tract (i.e., not dedicated to either clinical application). Typically, the catheter is advanced over the wire after the wire has been manoeuvred to a treatment site (e.g., site of stent-placement). It is available in a variety of diameters and lengths, may have fluoroscopic markers, or be fitted with an introducer for entering the working channel of the catheter or other interventional device. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 884789251
- Device count
- 1
- DM exempt
- false
- 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00816988010197 | Sonoma Orthopedic Products, Inc | 2.7mm Bone Screw Caddy/ Cover | IN0118 | 2015-09-17 |
| 00816988010739 | Sonoma Orthopedic Products, Inc | SONOMA WRX Inner Sterilization Case | IN0103 | 2015-09-17 |
| 00816988010746 | Sonoma Orthopedic Products, Inc | Screw Caddy With Peg Caddy | IN0104 | 2015-09-17 |
| 00816988012030 | Sonoma Orthopedic Products, Inc | Instrument Case | IN6800 | 2015-08-19 |
| 00816988012047 | Sonoma Orthopedic Products, Inc | Instrument Case Inner Tray | IN6801 | 2015-08-19 |
| 00816988012054 | Sonoma Orthopedic Products, Inc | Instrument Case Lid | IN6802 | 2015-08-19 |
| 00816988012368 | Sonoma Orthopedic Products, Inc. | Fib First Gen Bottom Insert Tray | IN6803 | 2017-07-07 |
| 00816988012467 | Sonoma Orthopedic Products, Inc. | Fibulock Instrument Gase Gen2 | IN6805 | 2016-02-04 |
| 00816988012474 | Sonoma Orthopedic Products, Inc. | Fibulock Instrument Case Base Gen2 | IN6805-01 | 2016-02-04 |
| 00816988012481 | Sonoma Orthopedic Products, Inc. | Fibulock Instrument Case Lid Gen2 | IN6805-02 | 2016-02-04 |
| 00816988012498 | Sonoma Orthopedic Products, Inc. | Fibulock Instrument Case Insert Tray Gen2 | IN6805-03 | 2016-02-04 |
| 00816988012504 | Sonoma Orthopedic Products, Inc. | Fibulock Instrument Case Screw Caddy and Lid Gen2 | IN6805-04 | 2016-02-04 |
| 00816988013068 | Sonoma Orthopedic Products, Inc. | Jones Bolt Instrument Tray Base | IN7800-01 | 2017-04-04 |
| 00816988013075 | Sonoma Orthopedic Products, Inc. | Jones Bolt Instrument Tray Lid | IN7800-02 | 2017-04-04 |
| 00816988013174 | Sonoma Orthopedic Products, Inc. | WRx Tray with Irremovable Innermost Tray | IN0149 | 2017-09-20 |
| 00816988011446 | Sonoma Orthopedic Products, Inc | CRx DISPOSABLE INTRUMENTS PACKAGE | ST0101_A | 2015-09-08 |
| 00816988010593 | Sonoma Orthopedic Products, Inc | WRx Outrigger | IN0150 | 2015-09-17 |
| 00816988010609 | Sonoma Orthopedic Products, Inc | 5mm Hub Attachment Tube "Outrigger" | IN0151 | 2015-09-17 |
| 00816988010616 | Sonoma Orthopedic Products, Inc | 5mm Hub Attachment Screw "Outrigger" | IN0152 | 2015-09-17 |
| 00816988010630 | Sonoma Orthopedic Products, Inc | 6mm Hub Attachment Screw "Outrigger" | IN0162 | 2015-09-17 |
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