FDA UDI
In Commercial Distribution
🇺🇸 United States
Steady Pro
DI: 03665134000592
·
Model: KPHA.OO.EC
·
KOELIS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Steady Pro
- Primary DI
- 03665134000592
- Version / Model
- KPHA.OO.EC
- Company Name
- KOELIS
- Labeler DUNS
- 290318455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 1
- Public Version Date
- 2020-07-27
- Public Version Status
- New
- Public Device Record Key
- d72957ac-39b4-4060-bfb2-8f42605c4ef4
Device Description
Steady Pro (Mechanical probe holder and supports) The steady pro range is intended to reliably maintain the position of a transrectal ultrasoung probe during untra-sound-guided intervention.
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62379 | Surgical instrument assist arm system, manually-adjusted | A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665134000592 | GS1 |
Customer Contacts
- Phone
- +33458176810
- [email protected]