FDA UDI
In Commercial Distribution
🇺🇸 United States
Coronary Bypass Marker
DI: B776106961
·
Model: Rev1
·
FIRST CALL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- Coronary Bypass Marker
- Primary DI
- B776106961
- Version / Model
- Rev1
- Catalog Number
- 10-696
- Company Name
- FIRST CALL, INC.
- Labeler DUNS
- 015526185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2019-10-03
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 3aee9866-a13e-4c4d-b860-8e3fe3868d13
Device Description
Suturing Washer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MAB | Marker, Cardiopulmonary Bypass (Vein Marker) | Cardiovascular | 870.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60866 | Metallic 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 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]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B776106961 | HIBCC | ||||
| Unit of Use | B7761069619 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052642 | 000 |