Stratum Foot Plating System
- Primary DI
- 00817701028055
- Brand
- Stratum Foot Plating System
- Company
- NEXTREMITY SOLUTIONS, INC.
- Model
- STRM-THDWIRE-NS
- Device description
- Stratum Non-Sterile Threaded Wire
- Published
- 2019-11-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
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 |
|---|---|---|---|---|
| 00817701028055 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00817701028055 | 00817701028055 | 817701028055 | 0817701028055 |
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
- 060783407
- 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
- true
- 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 |
|---|---|---|---|---|
| 00810082893885 | Stealthfix Intraosseous Fixation System | SF351514 | 2022-08-04 | |
| 00810082893892 | Stealthfix Intraosseous Fixation System | SF351516 | 2022-08-04 | |
| 00810082893908 | Stealthfix Intraosseous Fixation System | SF351518 | 2022-08-04 | |
| 00810082893915 | Stealthfix Intraosseous Fixation System | SF351520 | 2022-08-04 | |
| 00810082893922 | Stealthfix Intraosseous Fixation System | SF451514 | 2022-08-04 | |
| 00810082893939 | Stealthfix Intraosseous Fixation System | SF451516 | 2022-08-04 | |
| 00810082893946 | Stealthfix Intraosseous Fixation System | SF451518 | 2022-08-04 | |
| 00810082893953 | Stealthfix Intraosseous Fixation System | SF451520 | 2022-08-04 | |
| 00810082893960 | Stealthfix Intraosseous Fixation System | SF451522 | 2022-08-04 | |
| 00810082893977 | Stealthfix Intraosseous Fixation System | SF451524 | 2022-08-04 | |
| 00810082893984 | Stealthfix Intraosseous Fixation System | SF451526 | 2022-08-04 | |
| 00810082893991 | Stealthfix Intraosseous Fixation System | SF451528 | 2022-08-04 | |
| 00810082894004 | Stealthfix Intraosseous Fixation System | SF451530 | 2022-08-04 | |
| 00810082894011 | Stealthfix Intraosseous Fixation System | SF451532 | 2022-08-04 | |
| 00810082894028 | Stealthfix Intraosseous Fixation System | SF452014 | 2022-08-04 | |
| 00810082894035 | Stealthfix Intraosseous Fixation System | SF452016 | 2022-08-04 | |
| 00810082894042 | Stealthfix Intraosseous Fixation System | SF452018 | 2022-08-04 | |
| 00810082894059 | Stealthfix Intraosseous Fixation System | SF452020 | 2022-08-04 | |
| 00810082894066 | Stealthfix Intraosseous Fixation System | SF452022 | 2022-08-04 | |
| 00810082894073 | Stealthfix Intraosseous Fixation System | SF452024 | 2022-08-04 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00198506090998 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091001 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091018 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091025 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091032 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091049 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091056 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091063 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091070 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00198506091087 | ELMED INCORPORATED | ELMED INCORPORATED | LXH | 2026-05-26 |
| 00841523181360 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181681 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181698 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181704 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181711 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181728 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181735 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181742 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181759 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181766 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181773 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181780 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181797 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181803 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181810 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181827 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181834 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181841 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181858 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |
| 00841523181865 | Kyocera Medical Technologies, Inc. | KYOCERA MEDICAL TECHNOLOGIES, INC. | LXH | 2026-05-26 |