FDA Registration
Active
🇺🇸 United States
KATENA PRODUCTS, INC.
Reg #: 3015177648
·
FEI: 3015177648
·
Expires 2026
Products
65
Proprietary Names
39
Establishment Types
4
Classifications
65
Registration Details
- Registration Name
- KATENA PRODUCTS, INC.
- Registration Number
- 3015177648
- FEI Number
- 3015177648
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6 CAMPUS DRIVE, SUITE 310
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K883233
Owner / Operator
- Firm Name
- Corza Medical, Inc.
- Operator Number
- 2242450
- Address
- 2755 Canyon Boulevard, 1st Floor
- City
- Boulder
- State
- CO
- Postal Code
- 80302
- Country
- US
- Correspondent
- Alex Castillo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1993-01-01 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2019-08-28 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2016-02-08 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 1993-01-01 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2016-11-10 |
| Plug, Punctum | LZU | Class U | Unknown | No | 2016-10-08 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1993-01-01 |
| Applicator, Ocular Pressure | LCC | Class 2 | Ophthalmic | No | 2008-03-14 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2007-10-31 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2007-11-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-06-11 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2008-08-21 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2013-01-23 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2008-08-21 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 1977-12-08 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2007-10-08 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2007-11-19 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1993-01-01 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2009-06-24 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1993-01-01 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Prosthesis, Eyelid Spacer/Graft, Biologic | NXM | Class 2 | Ophthalmic | No | 2016-09-19 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1993-01-01 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 1993-01-01 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-10-31 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 1993-01-01 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2018-06-12 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2007-10-31 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1993-01-01 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 1993-01-01 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2001-08-29 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2021-07-29 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2013-06-10 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1993-01-01 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2001-08-29 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 1993-01-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1993-01-01 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2001-08-29 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1993-01-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2016-02-08 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1993-01-01 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 1993-01-01 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2022-04-12 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2013-06-10 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1993-01-01 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2016-02-08 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2007-11-02 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2001-08-29 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 1993-01-01 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 1993-01-01 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2016-02-08 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2009-06-11 |
Proprietary Names
GRAETHER
DuraPlug
Punctal Gauge
Eagle
Honan Balloon
multiple, needle holder names
Wright Fascia Needle
Diamond Knifes (multiple)
Clear Corneal Diamond Knife
Diamond Step Knife
Diamond Knife Crescent
AK Step Knife Double Footplate
Tooke Corneal Knife
Sharpoint
Lacrimal Cannula
Facial Infiltration Needle
Peribulbar Needle
Retrobulbar Needle
MALLET STAINLESS STEEL
EaglePlug TearFlow; Flow Controller
Eagle Flex; EaglePlug; Plug 1; SuperEagle; SuperFlex
tarSys
INSTRUMENT WIPES, PVA SPONGE
INSTRUMENT TIP GUARDS
Blink
Infant Speculum
Temporal Speculum
Castroviejo Lid Speculum
FLIERINGA FIXATION RING
MCNEILL GLOBAL FIXATION RING
GASS SCLERAL MARKER
Barron Donor Corneal Punches
Barron Vacuum Donor Punches
Barron Radial Vacuum Trephines
Katena Trephine Blades
WRIGHT FASCIA
Gulden
SHARPOINT
SURG-I-BAND; INSTR. MARKING TAPE
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Repack or Relabel Medical Device