FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FITBONE®
DI: 04260170143952
·
Model: TAA1180-F-245
·
WITTENSTEIN intens GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FITBONE®
- Primary DI
- 04260170143952
- Version / Model
- TAA1180-F-245
- Catalog Number
- 60001404-00-0
- Company Name
- WITTENSTEIN intens GmbH
- Labeler DUNS
- 315887799
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-22
- Public Version
- 8
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- e7abad13-9bb9-4e2e-8d3d-e812425cf33d
- Distribution End Date
- 2022-12-31
Device Description
Intramedullary lengthening nail
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63191 | Long bone distraction nail, motorized | An implantable, electrically-powered device in the form of a rod, capable of extending in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to correct limb length discrepancies. A rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia) and is used for traumatic repair or reconstructive procedures (e.g., leg lengthening). It consists of telescoping rods connected to the bone by locking screws, and a small motor to provide lengthening force which is controlled/powered by a remote controller device operating through an implanted receiver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260170143952 | GS1 |
Customer Contacts
- Phone
- +4979314930
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 11 | Millimeter | |
| Length | 245 | Millimeter |