FDA UDI
In Commercial Distribution
🇺🇸 United States
Magnetic Controller, Magnetic Surgical System
DI: 00852342007014
·
Model: MAG001
·
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
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
- Magnetic Controller, Magnetic Surgical System
- Primary DI
- 00852342007014
- Version / Model
- MAG001
- Company Name
- LEVITA MAGNETICS INTERNATIONAL CORPORATION
- Labeler DUNS
- 066172261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-16
- Public Version
- 5
- Public Version Date
- 2023-11-02
- Public Version Status
- Update
- Public Device Record Key
- 37825990-b0b8-4ab0-bdeb-7a89ad3cba3d
Device Description
Magnetic Controller, Magnetic Surgical System
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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PNL | Magnetic Surgical System | General, Plastic Surgery | 878.4815 | 2 |
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 | 00852342007014 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150007 | 000 |