FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 03664539000510
·
Model: STOP
·
DIXI MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 03664539000510
- Version / Model
- STOP
- Catalog Number
- ACS-760
- Company Name
- DIXI MEDICAL
- Labeler DUNS
- 268009609
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-01
- Public Version
- 2
- Public Version Date
- 2025-11-06
- Public Version Status
- Update
- Public Device Record Key
- 73cc6ae8-9b5a-4568-9d54-273e0229346b
- Distribution End Date
- 2025-11-05
Device Description
STOP FR MARKING ROD, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03664539000510 | GS1 |
Customer Contacts
- Phone
- +33381889890
- [email protected]