Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
- Primary DI
- B040FMPM21
- Brand
- Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
- Company
- GENESEE BIOMEDICAL, INC.
- Model
- FM-PM-2
- Device description
- Coronary Artery Bypass Graft Markers, Flexible Proximal
- Published
- 2017-02-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
- Single use
- true
Contact Domains#
geneseebiomedical.comProduct Codes#
| Code | Name |
|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K905067 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B040FMPM22 | Package | HIBCC | 2 | In Commercial Distribution |
| B040FMPM21 | Primary | HIBCC | 0 | |
| B040FMPM2 | Unit of Use | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Polymeric coronary bypass marker | A device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy]. |
Contacts#
| Phone | |
|---|---|
| 800 786-4890 | info@geneseebiomedical.com |
Regulatory Flags#
- DUNS number
- 939872651
- Device count
- 2
- DM exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
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|---|---|---|---|---|
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| B040RPS18500 | Thoracic Port with Obturator 18x50mm | RPS-1850 | 2026-03-25 | |
| B040RPS18700 | Thoracic Port with Obturator 18x70mm | RPS-1870 | 2026-03-25 | |
| B040RPS18900 | Thoracic Port with Obturator 18x90mm | RPS-1890 | 2026-03-25 | |
| B040TF260 | TransForm McCarthy Annuloplasty Ring | TF-26 | 2024-12-23 | |
| B040TF280 | TransForm McCarthy Annuloplasty Ring | TF-28 | 2024-12-23 | |
| B040TF300 | TransForm McCarthy Annuloplasty Ring | TF-30 | 2024-12-23 | |
| B040TF320 | TransForm McCarthy Annuloplasty Ring | TF-32 | 2024-12-23 | |
| B040TF340 | TransForm McCarthy Annuloplasty Ring | TF-34 | 2024-12-23 | |
| B040TF380 | TransForm McCarthy Annuloplasty Ring | TF-38 | 2024-12-23 | |
| B040TF400 | TransForm McCarthy Annuloplasty Ring | TF-40 | 2024-12-23 | |
| B040TF240 | TransForm McCarthy Annuloplasty Ring | TF-24 | 2024-12-23 | |
| B040TF26 | TransForm McCarthy Annuloplasty Ring | TF-26 | 2024-12-23 | |
| B040TF28 | TransForm McCarthy Annuloplasty Ring | TF-28 | 2024-12-23 | |
| B040TF30 | TransForm McCarthy Annuloplasty Ring | TF-30 | 2024-12-23 | |
| B040TF32 | TransForm McCarthy Annuloplasty Ring | TF-32 | 2024-12-23 | |
| B040TF34 | TransForm McCarthy Annuloplasty Ring | TF-34 | 2024-12-23 | |
| B040TF360 | TransForm McCarthy Annuloplasty Ring | TF-36 | 2024-12-23 | |
| B040TF38 | TransForm McCarthy Annuloplasty Ring | TF-38 | 2024-12-23 | |
| B040TF40 | TransForm McCarthy Annuloplasty Ring | TF-40 | 2024-12-23 |
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| 00733132600038 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600052 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600076 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132600090 | GORE Hybrid Vascular Graft-CBAS | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132605354 | GORE ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606290 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606313 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606351 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606375 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606399 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132606436 | GORE PROPATEN Vascular Graft Pediatric Shunt | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607068 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607129 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607143 | GORE PROPATEN Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607150 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607174 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607181 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607211 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607228 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607235 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607242 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607259 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607266 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607273 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607280 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607297 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
| 00733132607303 | GORE INTERING Vascular Graft | W. L. Gore & Associates, Inc. | DSY | 2017-02-13 |
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