FDA UDI
In Commercial Distribution
🇺🇸 United States
Leksell Guide Block Set
DI: 00841823104243
·
Model: LK-GB-N-13
·
Ad-Tech Medical Instrument Corporation
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leksell Guide Block Set
- Primary DI
- 00841823104243
- Version / Model
- LK-GB-N-13
- Catalog Number
- LK-GB-N-13
- 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
- 2017-12-27
- Public Version
- 3
- Public Version Date
- 2023-08-23
- Public Version Status
- Update
- Public Device Record Key
- 69f83aa4-ce2d-4f2c-9165-5fab1d3ae96a
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBG | DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) | Neurology | 882.4300 | 2 |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | Neurology | 882.4310 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00841823104243 | GS1 |
Customer Contacts
- Phone
- +1(800)776-1555
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- To be stored and used within typical hospital/office room ambient temperature and humidity conditions