FDA UDI
In Commercial Distribution
🇺🇸 United States
11" Stainless Steel Guidewire
DI: 00858406007587
·
Model: FC-G-16
·
SURGENTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 11" Stainless Steel Guidewire
- Primary DI
- 00858406007587
- Version / Model
- FC-G-16
- Company Name
- SURGENTEC, LLC
- Labeler DUNS
- 004095409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-07
- Public Version
- 1
- Public Version Date
- 2025-03-17
- Public Version Status
- New
- Public Device Record Key
- 77d623db-41aa-4eac-8f95-f62a31a61f6b
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | Unknown | U |
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 | 00858406007587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211855 | 000 |