AdvantageRib
- Primary DI
- 00854865007168
- Brand
- AdvantageRib
- Company
- SIG MEDICAL CORP.
- Model
- 323.1090
- Catalog number
- 323.1090
- Device description
- AdvantageRib Guide Cable
- Published
- 2018-10-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K141241 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00854865007168 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00854865007168 | 00854865007168 | 854865007168 | 0854865007168 |
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 |
Contacts#
| Phone | |
|---|---|
| 717-553-2021 | info@sigmedical.net |
Regulatory Flags#
- DUNS number
- 080503619
- Device count
- 1
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00854865007489 | AdvantageRib | 323.1010 | 323.1010 | 2019-08-20 |
| 00854865007496 | AdvantageRib | 323.1011 | 323.1011 | 2019-08-20 |
| 00854865007502 | AdvantageRib | 323.1012 | 323.1012 | 2019-08-20 |
| 00854865007519 | AdvantageRib | 323.1013 | 323.1013 | 2019-08-20 |
| 00854865007526 | AdvantageRib | 323.1020 | 323.1020 | 2019-08-20 |
| 00854865007533 | AdvantageRib | 323.1021 | 323.1021 | 2019-08-20 |
| 00854865007540 | AdvantageRib | 323.1022 | 323.1022 | 2019-08-20 |
| 00854865007557 | AdvantageRib | 323.1023 | 323.1023 | 2019-08-20 |
| 00854865007564 | AdvantageRib | 323.1030 | 323.1030 | 2019-08-20 |
| 00854865007571 | AdvantageRib | 323.1031 | 323.1031 | 2019-08-20 |
| 00854865007588 | AdvantageRib | 323.1032 | 323.1032 | 2019-08-20 |
| 00854865007595 | AdvantageRib | 323.1033 | 323.1033 | 2019-08-20 |
| 00854865007007 | AdvantageRib | 323.1001 | 323.1001 | 2018-10-03 |
| 00854865007014 | AdvantageRib | 323.1002 | 323.1002 | 2018-10-03 |
| 00854865007021 | AdvantageRib | 323.1003 | 323.1003 | 2018-10-03 |
| 00854865007038 | AdvantageRib | 323.1004 | 323.1004 | 2018-10-03 |
| 00854865007045 | AdvantageRib | 323.1005 | 323.1005 | 2017-02-17 |
| 00854865007052 | AdvantageRib | 323.1006 | 323.1006 | 2017-02-17 |
| 00854865007069 | AdvantageRib | 323.1007 | 323.1007 | 2017-02-17 |
| 00854865007076 | AdvantageRib | 1 | 04.517.010 | 2017-02-17 |
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