FDA UDI
In Commercial Distribution
🇺🇸 United States
COR-VASC Cam lock for articulated arm
DI: 00817121000419
·
Model: 1011592
·
Coroneo Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- COR-VASC Cam lock for articulated arm
- Primary DI
- 00817121000419
- Version / Model
- 1011592
- Catalog Number
- 1011592
- Company Name
- Coroneo Inc
- Labeler DUNS
- 255276362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-28
- Public Version
- 1
- Public Version Date
- 2023-07-06
- Public Version Status
- New
- Public Device Record Key
- c3b38b18-9d07-4a3a-b38c-ecb8b5598b5b
Device Description
The COR-VASC system is intended to be used for performing coronary artery bypass surgery on a beating or arrested heart. The Cam lock is intended to be used with the Articulated Arm components 1010937 and 1011593.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45181 | Surgical retraction system, reusable | A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817121000416 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00817121000419 | GS1 |