FDA Registration
Active
🇨🇦 Canada
SafeGauze Hemostat
Reg #: 9611959
·
FEI: 3002677549
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- AMD Medicom Inc.
- Registration Number
- 9611959
- FEI Number
- 3002677549
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2555 Chemin de l'Aviation
- City
- Pointe-Claire, Montreal Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K173196
Owner / Operator
- Firm Name
- AMD Medicom Inc.
- Operator Number
- 8020405
- Address
- 2555 Chemin de l'Aviation, --
- City
- Pointe-Claire (Montreal)
- State
- Quebec
- Postal Code
- H9P 2Z2
- Country
- CA
US Agent
- Business Name
- United Medical Enterprise
- Contact Name
- Brent Geiger
- Address
- 3301 Stagecoach, Rd NE Thomson
- City
- Thomson
- State
- GA
- ZIP
- 30824
- Country
- US
- [email protected]
- Phone
- 763 2189292
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2021-12-24 |
Proprietary Names
SafeGauze Hemostat
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device