NA
- Primary DI
- H679291040
- Brand
- NA
- Company
- SYNTHES (U.S.A.) LP
- Model
- 291.04
- Catalog number
- 29104
- Device description
- 1.25MM CERCLAGE WIRE WITH EYE 600MM
- Published
- 2015-09-14
- 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
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| JDQ | CERCLAGE, FIXATION |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JDQ | Cerclage, Fixation | Orthopedic | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 20886982180114 | Primary | GS1 | 0 | |
| H679291040 | Secondary | HIBCC | 0 | |
| 80886982180116 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 20886982180114 | 20886982180114 |
| 80886982180116 | 80886982180116 |
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 | |
|---|---|
| +1(800)255-2500 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 832637081
- Device count
- 10
- 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 |
|---|---|---|---|---|
| 10705034718040 | NA | 03.620.219 | 03620219 | 2018-10-29 |
| 10705034767802 | VentroFix | 304.832 | 304832 | 2016-12-31 |
| 10705034775418 | NA | 389.296 | 389296 | 2016-12-31 |
| 10705034775425 | NA | 389.297 | 389297 | 2016-12-31 |
| 10705034775432 | NA | 389.298 | 389298 | 2016-12-31 |
| 10705034775449 | NA | 389.299 | 389299 | 2016-12-31 |
| 10705034798455 | NA | 690.038 | 690038 | 2016-12-31 |
| 10887587039893 | NA | 338.761 | 338761 | 2016-12-31 |
| 10886982338778 | MAXFRAME | 1100022-01 | 110002201 | 2024-02-05 |
| 10886982338570 | MAXFRAME | 1100011-01 | 110001101 | 2022-04-26 |
| 10886982338587 | MAXFRAME | 1100010-01 | 110001001 | 2022-04-26 |
| 10886982338594 | MAXFRAME | 1100012-01 | 110001201 | 2022-04-26 |
| 10886982338600 | MAXFRAME | 1100007-01 | 110000701 | 2022-04-26 |
| 10886982237217 | NA | 510.161 | 510161 | 2019-02-21 |
| 10887587039305 | NA | 329.37 | 32937 | 2016-12-31 |
| 10705034741161 | NA | 04.616.135 | 04616135 | 2015-09-14 |
| 10705034741178 | NA | 04.616.140 | 04616140 | 2015-09-14 |
| 10705034741260 | NA | 04.616.185 | 04616185 | 2015-09-14 |
| 10705034741284 | NA | 04.616.195 | 04616195 | 2015-09-14 |
| 10886982027795 | NA | 02.007.000S | 02007000S | 2015-09-14 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00888867525924 | Arthrex® | ARTHREX, INC. | JDQ | 2025-10-20 |
| 00888867525931 | Arthrex® | ARTHREX, INC. | JDQ | 2025-10-20 |
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