FDA UDI
In Commercial Distribution
🇺🇸 United States
INTREPED, Intraosseous Fusion Device
DI: 00850055649408
·
Model: 01-40208
·
Auxano Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INTREPED, Intraosseous Fusion Device
- Primary DI
- 00850055649408
- Version / Model
- 01-40208
- Catalog Number
- 01-40208
- Company Name
- Auxano Medical LLC
- Labeler DUNS
- 119185571
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-24
- Public Version
- 1
- Public Version Date
- 2025-04-01
- Public Version Status
- New
- Public Device Record Key
- 5a0623ff-ddf0-48e7-b2d5-9a91d0b17998
Device Description
INTREPED 08 Driver
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66947 | Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850055649408 | GS1 |
Customer Contacts
- Phone
- 4402622000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231649 | 000 |