FDA UDI
In Commercial Distribution
🇺🇸 United States
Aortic Repair Tool Kit
DI: B040ART2
·
Model: ART-2
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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
- Aortic Repair Tool Kit
- Primary DI
- B040ART2
- Version / Model
- ART-2
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-11
- Public Version
- 1
- Public Version Date
- 2024-06-19
- Public Version Status
- New
- Public Device Record Key
- 9276cbc0-a981-4f4b-b74c-324863ba0781
Device Description
Aortic Repair Tool Kit containing Cusp Calipers and Annular Sizers
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 47684 | Heart valve annulus sizer, reusable | A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device. | No | Active |
| 66723 | Aortic valve cusp height ruler | A hand-held manual surgical instrument intended to be used during aortic valve repair and root remodelling to measure aortic valve cusp height. It is a double-ended graduated tool with one straight-edged end used to measure effective cusp height, and one hooked end used to measure geometric cusp height. It is typically available in a set of varying sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B040ART2 | HIBCC |