FDA UDI
In Commercial Distribution
🇺🇸 United States
Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings
DI: B040AMGMBD1
·
Model: AMGM-BD
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Anastomark Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings
- Primary DI
- B040AMGMBD1
- Version / Model
- AMGM-BD
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 308ee92a-8cfe-4878-8def-05ca4165f66d
Device Description
Coronary Artery Bypass Graft Markers, Bulk Distal Marker Rings
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 60865 | Metallic coronary bypass marker, sterile | A sterile 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 metal (e.g., stainless steel) ring which is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy]. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B040AMGMBD1 | HIBCC | ||||
| Unit of Use | B040AMGMBD100 | HIBCC |