FDA UDI
In Commercial Distribution
🇺🇸 United States
Toothed Grasper, Magnetic Surgical System
DI: 00852342007007
·
Model: TGR001
·
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Toothed Grasper, Magnetic Surgical System
- Primary DI
- 00852342007007
- Version / Model
- TGR001
- Company Name
- LEVITA MAGNETICS INTERNATIONAL CORPORATION
- Labeler DUNS
- 066172261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c60657f5-29b6-48e3-a27d-b8aef40f58f8
Device Description
Magnetic Surgical System Toothed Grasper,
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
- No
- 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 |
|---|---|---|---|---|
| PNL | Magnetic Surgical System | General, Plastic Surgery | 878.4815 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62415 | Magnetic surgical manipulation system instrument, internal | A sterile, invasive, magnetic device intended to be percutaneously inserted into the body to be used as a manoeuvrable object to permit transcutaneous grasping/manipulation/retraction of soft tissues/organs (e.g., gallbladder) during endoscopic/laparoscopic procedures, via magnetic coupling with an external magnetic device moved across the patient’s body surface by the operator. It is made of plastic and metal materials and may be in the form of a grasper, bent rod, or other shape designed to contact the target tissue/organ; dedicated tools to assist its insertion/retrieval are typically included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852342007007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN150007 | 000 |