FDA UDI
In Commercial Distribution
🇺🇸 United States
MARS Scope Holder
DI: 00852342007076
·
Model: DRA002-04
·
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MARS Scope Holder
- Primary DI
- 00852342007076
- Version / Model
- DRA002-04
- Company Name
- LEVITA MAGNETICS INTERNATIONAL CORPORATION
- Labeler DUNS
- 066172261
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-14
- Public Version
- 1
- Public Version Date
- 2023-09-22
- Public Version Status
- New
- Public Device Record Key
- 1ff523f3-c54c-4832-8dd7-ff29d34362f0
Device Description
MARS Scope Holder
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
- No
- 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 |
|---|---|---|---|---|
| PNL | Magnetic Surgical System | General, Plastic Surgery | 878.4815 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62417 | Magnetic surgical manipulation system instrument, external, electric | A noninvasive, mains electricity (AC-powered), hand-held electromagnetic 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 is made of metal and plastic materials and is 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 | 00852342007076 | GS1 |