FDA Registration
Active
🇺🇸 United States
Zimmer (LN) - precision flexible reamer disposable 7mm
Reg #: 1220477
·
FEI: 1220477
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1220477
- FEI Number
- 1220477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 435 WHITNEY ST.
- City
- Northboro
- State
- MA
- ZIP
- 01532
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reamer | HTO | Class 1 | Orthopedic | No | 2013-01-07 |
Proprietary Names
Zimmer (LN) - precision flexible reamer disposable 7mm
Zimmer (LN) - precision flexible reamer disposable 10mm
Zimmer (LN)- PRECISION FLX RMR 5.5MM DISP
Zimmer (LN) - precision flexible reamer disposable 8.5mm
Zimmer (LN) - precision flexible reamer disposable 11.5mm
Zimmer (LN) - precision flexible reamer disposable 11mm
Zimmer (LN, LS) - Trauma Fixation Systems
Zimmer (LN) - precision flexible reamer disposable 10.5mm
Zimmer (LN) - precision flexible reamer disposable 9.5mm
Zimmer (LN) - precision flexible reamer disposable 7.5mm
Zimmer (LN) - PRECISION FLX RMR 6.5MM DISP
Zimmer (LN) - precision flexible reamer disposable 8mm
Zimmer (LN)- PRECISION FLX RMR 6MM DISP
Zimmer (LN) - precision flexible reamer disposable 9mm
Zimmer (LN) - PRECISION FLX RMR 5MM DISP
Zimmer (LN) - precision flexible reamer disposable 4.5mm
Zimmer (LN) - precision flexible reamer disposable 12mm
Viant8257 (NR,WH*) - Reamer
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)