FDA UDI
In Commercial Distribution
🇺🇸 United States
LiV™ Instruments
DI: 00818354013177
·
Model: 001-340-7480
·
ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LiV™ Instruments
- Primary DI
- 00818354013177
- Version / Model
- 001-340-7480
- Catalog Number
- N/A
- Company Name
- ATRICURE, INC.
- Labeler DUNS
- 006133784
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 2
- Public Version Date
- 2023-06-19
- Public Version Status
- Update
- Public Device Record Key
- c07ae49f-213f-4596-a02e-d9b6baf53056
Device Description
LiV Magnetic Probe
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 62416 | Magnetic surgical manipulation system instrument, external, permanent magnet | A noninvasive, hand-held, magnetic surgical device intended to be moved across a patient’s body surface to magnetically couple with and control the manoeuvring of an invasive instrument percutaneously inserted into the body, to permit transcutaneous grasping/manipulation/retraction of soft tissues/organs (e.g., gallbladder) during endoscopic/laparoscopic procedures. It includes a permanent magnet and is made of metal and plastic materials in the form of a gliding pad. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818354013177 | GS1 |
Customer Contacts
- Phone
- 866-349-2342
- [email protected]