FDA UDI
In Commercial Distribution
🇺🇸 United States
Illico
DI: 00844856043930
·
Model: 73703
·
ALPHATEC SPINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Illico
- Primary DI
- 00844856043930
- Version / Model
- 73703
- Company Name
- ALPHATEC SPINE, INC.
- Labeler DUNS
- 602465783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-23
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 861c4221-2bad-4a09-ac9a-c3a4f6979f47
Device Description
STAINLESS STEEL GUIDEWIRE
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63819 | Spinal guidewire | A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844856043930 | GS1 |
Customer Contacts
- Phone
- +1(760)431-9286
- [email protected]