FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FITBONE®
DI: 04260170141651
·
Model: Transmitter
·
WITTENSTEIN intens GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FITBONE®
- Primary DI
- 04260170141651
- Version / Model
- Transmitter
- Catalog Number
- 60001149
- 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
- 2023-01-06
- Public Version Status
- Update
- Public Device Record Key
- 63b5b46a-68cb-4826-b3de-66f5a2cd28fb
- Distribution End Date
- 2022-12-31
Device Description
Transcutaneous Energy Transmitter - part of Control Set
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 43538 | Distraction plate/rod adjustment remote control | A portable, hand-held, electrically-powered device intended to be used to noninvasively and remotely adjust the length of a previously-implanted orthopaedic distraction plate and/or rod (nail) to achieve the correct length; it may be used intraoperatively to test the functionality of the plate/rod. It is intended to be used with extramedullary distraction plates and/or intramedullary distraction rods to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rods to correct spinal deformities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260170141651 | GS1 |
Customer Contacts
- Phone
- +4979314930
- [email protected]