FDA UDI
In Commercial Distribution
🇺🇸 United States
2.8mm Spiked Start Sleeve
DI: 10850070500385
·
Model: CSS-001-LP
·
CURVAFIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 2.8mm Spiked Start Sleeve
- Primary DI
- 10850070500385
- Version / Model
- CSS-001-LP
- Catalog Number
- CSS-001-LP
- Company Name
- CURVAFIX, INC.
- Labeler DUNS
- 039779098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 2
- Public Version Date
- 2026-04-06
- Public Version Status
- Update
- Public Device Record Key
- 6199e247-0cb8-432e-be3d-386319f98e2b
Device Description
Handled cannulated tube with sharp tip helps align guide pin to determine bone entry point.
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
- 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 |
|---|---|---|---|---|
| 47831 | Orthopaedic implantation sleeve, reusable | A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850070500385 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]