FDA UDI
In Commercial Distribution
🇺🇸 United States
Long Smooth 2.8mm Guide Pin
DI: 10850070500071
·
Model: GPS-001-SP
·
CURVAFIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Long Smooth 2.8mm Guide Pin
- Primary DI
- 10850070500071
- Version / Model
- GPS-001-SP
- Catalog Number
- GPS-001-SP
- Company Name
- CURVAFIX, INC.
- Labeler DUNS
- 039779098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-23
- Public Version
- 2
- Public Version Date
- 2026-04-06
- Public Version Status
- Update
- Public Device Record Key
- 0c8e277a-f13e-4bb0-a8a4-645348e3b8de
Device Description
A thin wire with a sharp, smooth tip. Provides a starting location for the Step Drill. Fits within the Spiked Start Sleeve. L=455 mm. Supplied in a single sterile barrier package placed in shelf carton.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 62729 | Orthopaedic guidewire, single-use | A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850070500071 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 455 | Millimeter |