FDA UDI
In Commercial Distribution
🇺🇸 United States
InnoWave
DI: 00724995152741
·
Model: Pro
·
MEDISAFE UK LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- InnoWave
- Primary DI
- 00724995152741
- Version / Model
- Pro
- Catalog Number
- IWPRO60
- Company Name
- MEDISAFE UK LIMITED
- Labeler DUNS
- 505942961
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-21
- Public Version
- 7
- Public Version Date
- 2023-11-21
- Public Version Status
- Update
- Public Device Record Key
- a0b1d5b3-6b23-4c66-8c3e-7e427aa8aec3
Device Description
The InnoWave Pro Sonic Irrigator is a High-Pressure, Ultrasonic, Flushing Washer Disinfector for the medical market. It is intended to provide ultrasonic cleaning and low-level thermal disinfection of surgical instruments, including complex lumen/cannulated devices, such as robotic surgical instruments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MEC | Disinfector, medical devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66797 | Surgical instrument washer/disinfector (chemical/thermal) | An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995152741 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]