Sonoma Orthopedic Products, Inc
- Primary DI
- 00816988011934
- Brand
- Sonoma Orthopedic Products, Inc
- Company
- SONOMA ORTHOPEDIC PRODUCTS, INC.
- Model
- 1.25mm x 6" K-Wire
- Catalog number
- CS6013-6
- 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
- true
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 |
|---|---|---|---|---|
| 00816988011934 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00816988011934 | 00816988011934 | 816988011934 | 0816988011934 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone wire | A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. 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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