FDA UDI
In Commercial Distribution
🇺🇸 United States
SureCUT
DI: 00818354017595
·
Model: 5001
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SureCUT
- Primary DI
- 00818354017595
- Version / Model
- 5001
- Catalog Number
- 5001
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-30
- Public Version
- 2
- Public Version Date
- 2020-04-16
- Public Version Status
- Update
- Public Device Record Key
- e728c89a-7011-47c2-a174-4c1a08d4c791
Device Description
A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.
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
- 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
- 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 |
|---|---|---|---|---|
| FZT | Cutter, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64565 | Pericardioscopic access cannula | A rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest and through the pericardial cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive cardiac procedure (e.g., epicardial ablation). It is intended for subxiphoid or transdiaphragmatic access, and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade intended to assist introduction. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818354017595 | GS1 | ||||
| Previous | M95550010 | HIBCC |