FDA Registration
Active
🇺🇸 United States
BIOSURE TAP TRAY
Reg #: 1219602
·
FEI: 1219602
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 1219602
- FEI Number
- 1219602
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
- City
- MANSFIELD
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090562
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2014-06-19 |
Proprietary Names
BIOSURE TAP TRAY
ACUFEX ANATOMIC ACL DOUBLE BUNDLE INSTRUMENT TRAY
Instrument Tray
CROSSTRAC TRAY INCLUDED IN SYSTEM
EASY TAPS TRAY
ACUFEX EXTRA ARTICULAR RECON SYSTEM TRAY
ELITE PREMIUM BICEPS TENODESIS TRAY
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device