FDA Registration
Active
🇺🇸 United States
GUS ASTRA VR Endovaginal/Endorectal Probe Reprocesor
Reg #: 1937223
·
FEI: 1937223
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CIVCO Medical Instruments Co., Inc.
- Registration Number
- 1937223
- FEI Number
- 1937223
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 102 FIRST ST. SOUTH
- City
- Kalona
- State
- IA
- ZIP
- 52247
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150504
Owner / Operator
- Firm Name
- CIVCO Medical Instruments Co., Inc.
- Operator Number
- 1937223
- Address
- 750 Lois Lane, --
- City
- Coralville
- State
- IA
- Postal Code
- 52241
- Country
- US
- Correspondent
- JIM - LEONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | PSW | Class 2 | Radiology | No | 2016-11-21 |
Proprietary Names
GUS ASTRA VR Endovaginal/Endorectal Probe Reprocesor
GUS ASTRA TEE Transesophageal Probe Reprocessor
Establishment Types
Manufacture Medical Device