FDA UDI
In Commercial Distribution
🇺🇸 United States
Footswitch SupraFuser
DI: 07649990202358
·
Model: Footswitch SupraFuser
·
Surgical Fusion Technologies GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Footswitch SupraFuser
- Primary DI
- 07649990202358
- Version / Model
- Footswitch SupraFuser
- Catalog Number
- FS04-002
- Company Name
- Surgical Fusion Technologies GmbH
- Labeler DUNS
- 482948937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 1
- Public Version Date
- 2024-02-13
- Public Version Status
- New
- Public Device Record Key
- 25f208ef-ef37-4043-a1d1-a2bf622ad3c3
Device Description
Replacement for Footswitch BoneWelder 150-W1.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | 878.5000 | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | 888.3030 | 2 |
| HTY | Pin, Fixation, Smooth | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36336 | Foot-switch, electrical | An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07649990202358 | GS1 |
Customer Contacts
- Phone
- +41 442046018
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171228 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal