FDA UDI
In Commercial Distribution
🇺🇸 United States
Anchor Bolt Kit, LSB Style
DI: 00841823108814
·
Model: LSBK1-AX-05
·
Ad-Tech Medical Instrument Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Anchor Bolt Kit, LSB Style
- Primary DI
- 00841823108814
- Version / Model
- LSBK1-AX-05
- Catalog Number
- LSBK1-AX-05
- Company Name
- Ad-Tech Medical Instrument Corporation
- Labeler DUNS
- 174813410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-08
- Public Version
- 1
- Public Version Date
- 2026-04-16
- Public Version Status
- New
- Public Device Record Key
- 0aa8747f-5ac7-4de8-80de-c83cfa0cd19b
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 90841823108817 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 00841823108814 | GS1 |
Customer Contacts
- Phone
- +1(800)776-1555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223276 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- To be stored and used within typical hospital/office room ambient temperature and humidity conditions