FDA UDI
In Commercial Distribution
🇺🇸 United States
Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
DI: B040FMPM31
·
Model: FM-PM-3
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
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Basic Information
- Brand Name
- Anastomark Coronary Artery Bypass Graft Markers, Flexible Proximal
- Primary DI
- B040FMPM31
- Version / Model
- FM-PM-3
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 12e85959-f03c-4324-8a49-878643f45294
Device Description
Coronary Artery Bypass Graft Markers, Flexible Proximal
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60867 | 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]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B040FMPM32 | HIBCC | 3 | In Commercial Distribution | ||
| Primary | B040FMPM31 | HIBCC | ||||
| Unit of Use | B040FMPM3 | HIBCC |
Customer Contacts
- Phone
- 800 786-4890
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K905067 | 000 |