FDA UDI
In Commercial Distribution
🇺🇸 United States
9.0mm Drill Sleeve
DI: 10850070500408
·
Model: CDS-001-LP
·
CURVAFIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 9.0mm Drill Sleeve
- Primary DI
- 10850070500408
- Version / Model
- CDS-001-LP
- Catalog Number
- CDS-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
- 6a9e4d71-984b-4130-9ab7-e33a940ac871
Device Description
Sleeve fits inside Soft Tissue Sleeve or can be used alone, designed for percutaneous access of the Step Drill, Steerable Guide Sleeve, Exchange Tube and Driving Guidewire.
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 | 10850070500408 | GS1 |
Customer Contacts
- Phone
- 425-276-8800
- [email protected]