FDA Registration
Active
🇺🇸 United States
Reprocessed MyoSure REACH Tissue Removal Device
Reg #: 3030153385
·
FEI: 3030153385
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Stryker Sustainability Solutions - Chandler
- Registration Number
- 3030153385
- FEI Number
- 3030153385
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6635 W Frye Rd
- City
- Chandler
- State
- AZ
- ZIP
- 85226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201756
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2020-10-05 |
Proprietary Names
Reprocessed MyoSure REACH Tissue Removal Device
Reprocessed MyoSure Tissue Removal Device
Reprocessed MyoSure LITE Tissue Removal Device
Reprocessed MyoSure XL Tissue Removal Device
Reprocessed MyoSure XL Tissue Removal Device for Fluent
Establishment Types
Reprocess Single-Use Device