FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 03664539000671
·
Model: ANCHOR BOLT
·
DIXI MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- NA
- Primary DI
- 03664539000671
- Version / Model
- ANCHOR BOLT
- Catalog Number
- ACS-025SMS-10
- Company Name
- DIXI MEDICAL
- Labeler DUNS
- 268009609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-12-14
- Public Version
- 5
- Public Version Date
- 2021-12-01
- Public Version Status
- Update
- Public Device Record Key
- 38b99aef-c522-4dbb-9e9a-d3d1a5a4a57c
Device Description
SET OF 10 ANCHOR BOLTS, LENGTH 25MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
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
- Yes
- 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 |
|---|---|---|---|---|
| GZL | Electrode, Depth | Neurology | 882.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32556 | Depth electrode | An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03664539000671 | GS1 | ||||
| Unit of Use | 03664539003290 | GS1 |
Customer Contacts
- Phone
- +33381889890
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170959 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Millimeter |