FDA Registration
Active
🇺🇸 United States
Sterile Pelvic Exam Kits
Reg #: 2027062
·
FEI: 2027062
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BIOSEAL
- Registration Number
- 2027062
- FEI Number
- 2027062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 167 WEST ORANGETHORPE AVE.
- City
- PLACENTIA
- State
- CA
- ZIP
- 92870
- Country
- US
Owner / Operator
- Firm Name
- BIOSEAL
- Operator Number
- 2027062
- Address
- 167 WEST ORANGETHORPE AVE., --
- City
- Placentia
- State
- CA
- Postal Code
- 92870
- Country
- US
- Correspondent
- WILLIAM L RUNION
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 1992-11-12 |
Proprietary Names
Sterile Pelvic Exam Kits
Sterile Laceration Trays
Sterile Suturing Tray
Sterile Suture Removal Set
Sterile Dressing Change Kit
Sterile General Instrument Set
Sterile Circumcision Trays
Spectrum Syringe/Lateral Flow Vented Needle Pack
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device