FDA Registration
Active
🇺🇸 United States
KATENA PRODUCTS, INC.
Reg #: 2242450
·
FEI: 2242450
·
Expires 2026
Products
70
Proprietary Names
43
Establishment Types
4
Classifications
70
Registration Details
- Registration Name
- KATENA PRODUCTS, INC.
- Registration Number
- 2242450
- FEI Number
- 2242450
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4 Middlebury Boulevard, Unit #1
- City
- Randolph
- State
- NJ
- ZIP
- 07869
- Country
- US
Regulatory Submissions
- 510(k) Number
- K897190
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 |
|---|---|---|---|---|---|
| Plug, Punctum | LZU | Class U | Unknown | No | 2016-10-08 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2016-11-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-10-31 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2016-02-08 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1993-01-01 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2016-11-14 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1993-01-01 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2007-11-02 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1993-01-01 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2001-08-29 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2009-06-24 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1993-01-01 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2016-02-08 |
| Prism, Gonioscopic | HKS | Class 1 | Ophthalmic | No | 2016-02-08 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2013-06-10 |
| 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 |
| Tonometer, Manual | HKY | Class 2 | Ophthalmic | No | 2007-10-08 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2001-08-29 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2021-07-29 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2013-01-23 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1993-01-01 |
| Applicator, Ocular Pressure | LCC | Class 2 | Ophthalmic | No | 2008-03-14 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 1993-01-01 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2001-08-29 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 1993-01-01 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2009-06-11 |
| Burr, Corneal, Battery-Powered | HOG | Class 1 | Ophthalmic | No | 2007-10-08 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2008-08-21 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2022-04-12 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2001-08-29 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 1993-01-01 |
| Punch, Corneo-Scleral | HNJ | 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 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2007-10-31 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1993-01-01 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2007-10-31 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 1993-01-01 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2019-08-28 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1993-01-01 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1977-12-08 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Strip, Schirmer | KYD | Class 1 | Ophthalmic | No | 2016-11-10 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 1993-01-01 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Prosthesis, Eyelid Spacer/Graft, Biologic | NXM | Class 2 | Ophthalmic | No | 2016-09-19 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1993-01-01 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 1977-12-08 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 1993-01-01 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 1993-01-01 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1993-01-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 1993-01-01 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2013-06-10 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1993-01-01 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 1993-01-01 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2007-10-08 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Dilator, Lachrymal | HNW | 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 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 1993-01-01 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1993-01-01 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1993-01-01 |
Proprietary Names
INSTRUMENT WIPES, PVA SPONGE
INSTRUMENT TIP GUARDS
Blink
Eagle Flex; EaglePlug; Plug 1; SuperEagle; SuperFlex
Diamond Knifes (multiple)
Clear Corneal Diamond Knife
Diamond Step Knife
Diamond Knife Crescent
AK Step Knife Double Footplate
Tooke Corneal Knife
Sharpoint
Gulden
Punctal Gauge
Eagle
Lacrimal Cannula
Facial Infiltration Needle
Peribulbar Needle
Retrobulbar Needle
Infant Speculum
Temporal Speculum
Castroviejo Lid Speculum
multiple, needle holder names
GRAETHER
Honan Balloon
FLIERINGA FIXATION RING
MCNEILL GLOBAL FIXATION RING
SURG-I-BAND; INSTR. MARKING TAPE
LID LOAD
Ophthalmic Burr
Wright Fascia Needle
DuraPlug
Barron Donor Corneal Punches
Barron Vacuum Donor Punches
Barron Radial Vacuum Trephines
Katena Trephine Blades
KATENA DISPOSABLES
EaglePlug TearFlow; Flow Controller
MALLET STAINLESS STEEL
GASS SCLERAL MARKER
tarSys
WRIGHT FASCIA
SHARPOINT
Surgical Marking Pen
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device