FDA UDI
In Commercial Distribution
🇺🇸 United States
SONICWELD RX
DI: 00888118085115
·
Model: 52-504-04-91
·
KLS-Martin L.P.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SONICWELD RX
- Primary DI
- 00888118085115
- Version / Model
- 52-504-04-91
- Company Name
- KLS-Martin L.P.
- Labeler DUNS
- 826499238
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 6
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- 7f34b932-78f0-4c21-98a3-e5beb761fd18
Device Description
CLIP, FOR FINGER SWITCH CABLE
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
- 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 |
|---|---|---|---|---|
| JEY | PLATE, BONE | Dental | 872.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45882 | Bone pin ultrasonic osteosynthesis system | An assembly of devices intended to produce and apply ultrasonic vibration for heat to briefly melt (weld) a bioabsorbable fixation pin in a surgically pre-drilled bone hole to allow its fusion and anchoring within the bone (osseointegration), and enable its bonding with a fixation plate used for internal fixation (osteosynthesis). It includes a high frequency electrical current energy generator, a sonotrode handpiece for energy conversion into mechanical oscillation, and sonotrode tips for energy application; implants are not included. It’s used in craniomaxillofacial (CMF), orthopaedic, and neurological surgical procedures (e.g., paediatric corrective surgery for Apert or Crouzon syndrome). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888118085115 | GS1 |
Customer Contacts
- Phone
- +1(904)641-7746
- [email protected]