FDA UDI
In Commercial Distribution
🇺🇸 United States
STAINLESS STEEL TIBIAL NAILING SYSTEM
DI: 18032568034868
·
Model: 1
·
ORTHOFIX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STAINLESS STEEL TIBIAL NAILING SYSTEM
- Primary DI
- 18032568034868
- Version / Model
- 1
- Catalog Number
- 17484
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-28
- Public Version
- 1
- Public Version Date
- 2018-05-29
- Public Version Status
- New
- Public Device Record Key
- da641db4-65fb-4bd5-afcf-a7c963a9ab89
Device Description
U-SHAPED STABILIZING SPACER 10/11 MM FOR TIBIAL NAIL
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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47913 | Bone-nailing spacer | A cylindrical rod-like device used as a precision reference to provide the correct spatial distance between an an intramedullary bone nail (femoral, humeral, tibial) to which it is interfaced, and an aiming arm, joining the two in a relative position. This procedure is performed to set-up the aiming arm prior to surgery; the set-up is dismantled and then reconnected after implantation of the nail with this device (the spacer) which is percutaneously introduced into a selected hole in the bone nail. It is typically made of high-grade stainless steel or synthetic materials. Several reference spacers may be used for this procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18032568034868 | GS1 |
Customer Contacts
- Phone
- +0390456719000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 32 | Millimeter |