FDA Registration
Active
🇺🇸 United States
Kratz-Barraquer Wire Speculum
Reg #: 3007589150
·
FEI: 3007589150
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- KATALYST SURGICAL, LLC
- Registration Number
- 3007589150
- FEI Number
- 3007589150
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 754 Goddard ave
- City
- Chesterfield
- State
- MO
- ZIP
- 63005
- Country
- US
Owner / Operator
- Firm Name
- Katalyst Surgical, LLC
- Operator Number
- 10029103
- Address
- 754 Goddard Avenue
- City
- Chesterfield
- State
- MO
- Postal Code
- 63005
- Country
- US
- Correspondent
- Meryl Koch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2012-05-08 |
Proprietary Names
Kratz-Barraquer Wire Speculum
Sauer Lid Speculum
Closed Loop Wire Speculum
Mini Wire Speculum
Ginsberg Eye Speculum
Slade LASIK Eye Speculum
Genisi LASIK Speculum
LASIK Wire Speculum
Lieberman Solid Speculum
Mini Nagahara Wire Speculum
Steinert LASIK ACS Speculum
Nagahara Wire Speculum
Cook Eye Speculum
Slade LASIK Wire Speculum
Barraquer Solid Blade Speculum
Lieberman Open V-Wire Speculum
Lindstrom-Chu Aspirationg Speculum
Grandon Wire Speculum
Lieberman-Kratz Open Wire Speculum
Eye Speculum
Reversible Solid Blade Speculum
Alfonso Eye Speculum
Shapira Eye Speculum
Wire Speculum
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device