FDA Registration
Active
🇺🇸 United States
0485-840-000 - XL Round Diamond Bur, 4 mm
Reg #: 3015967359
·
FEI: 3015967359
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Stryker Instruments
- Registration Number
- 3015967359
- FEI Number
- 3015967359
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1941 Stryker Way
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
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 |
|---|---|---|---|---|---|
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2004-11-15 |
Proprietary Names
0485-840-000 - XL Round Diamond Bur, 4 mm
0485-860-000 - XL Round Diamond Bur, 5.5 mm
Bursector 5.5 mm
Bursector 4 mm
Tomcat HC Shaver Blade 4mm
Dual Edge Shaver Blade 4mm
Dual Edge Shaver Blade 3.5mm
Dual Edge Shaver Blade 5.5mm
Aggressive Max Shaver Blade 3.5mm
Smooth Bite Shaver Blade 3.5mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198