Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013421458

FEI Number

3013421458

Entity Name

Beaver-Visitec International, Inc.

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

Valle del Cedro No. 1520, Parque Industrial Intermex, Ciudad Juarez Chihuahua CP 32575, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Beaver-Visitec International, Inc. (Owner Number: 10033379)

Owner / Operator Contact Address

500 Totten Pond Rd, 10 CityPoint, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Beaver Visitec International Corneal Trephine Beaver Iowa P.K. Press Cutting Block Beaver Replacement Teflon Block Beaver Iowa P.K. Press Beaver Troutman Corneal Punch Piston Lacrimal Trephine Y Shape Corneal Marker Horizontal Axis Marker Toric Marker Double-Ring Corneal Marker Visitec® Visimark Corneal Marking Pad Mendez Gauge S Marker Corneal Epithelium Spatula Spatula PRK Spatula Daya Descemets Scraper Barraquer Iris Spatula Corneal Epithelium Spatula, Round Spatula, [Pearce], .80mm (45 Degree) Excimer Spatula, Lindstrom / Vorkas Accu-Temp High Temperature Cautery Accu-Temp Low Temperature Cautery Merocel Diamond Cleaning Block BVI Ophthalmic Cannula Bishop Harmon Cannula Small Incision Irrigating Vectis Transcleral Drainage Cannula LASIK Flap Irrigator Posterior Scraper Cortex Extractor ViscoExpression Cannula Visitec Nucleus Hydrodissector Irrigating Cannulas Infusion Cannulas LASIK Flap Spatula/Irrigator Anterior Chamber Cannula Anterior Chamber Cannula [Rycroft] Silicone Oil Removal Cannula Micro Irrigating Vectis Tapered Hydrodelineator Membrane Micropick Visitec Irrigation Handle 50 Cannula Viscoflow® Cannula High Viscosity Injector I and A Cannula Vitreoretinal Brush LASIK Cannula Lacrimal Cannula Coaxial I and A Cannula Leatherbarrow Pellet Insertion Cannula 5 SP Vitreoretinal Cannula Capsule Polisher HydroExpression Cannula Sub-Tenons Anesthesia Cannula Micro J Shape Hydrodissector Subretinal Injector FLACS Cannula J Shape Cannula Olive Tip Cannula LASEK Cannula Nucleus Hydrodissector LASIK Irrigating Cannula Subretinal Fluid Cannula Micro J Shape Cannula Soft Tip Cannula Irrigating Vectis Cortical Cleaving Hydrodissector Olive Tip Polisher Flexible Tip Cannula Bimanual Irrigation Cannula Visitec® Irrigation Handle Visitec® Single Fluid Administration Set Visitec® Double Male Luer Visitec® High Flow Filter Wet-Field® Eraser® 20-23 GA Tapered Blunt Tip Straight Wet-Field ® Eraser® 25 GA Fine Tip Straight Wet-Field® Eraser®, 20GA Blunt Tip 135 Degree Wet-Field® Eraser®, 20GA Blunt Tip Straight Wet-Field® Eraser®, 23GA Blunt Tip 135 Degree Wet-Field ® Eraser® 23 GA Fine Tip Straight Wet-Field® Eraser® 20-23 GA Tapered Fine Tip Straight Wet-Field ® Eraser® 25 GA Fine Tip 150 Degree Wet-Field ® Eraser®, 18GA Bevel Tip Wet-Field® Eraser®, 20GA Blunt Tip 150 Degree Wet-Field ® Eraser® 25 GA Fine Tip 135 Degree Wet-Field® Osher ThermoDot® Marker 25GA fine tip Wet-Field ® Eraser® 23 GA Fine Tip 150 Degree Wet-Field ® Eraser® 23 GA Fine Tip 135 Degree Wet-Field® Eraser®, 23GA Blunt Tip Straight Wet-Field® Eraser®, 18GA Blunt Tip 45 Degree Wet-Field® Single Use Bipolar Cable I-Ring® Pupil Expander Beaver® Swivel Fixation Ring Extend 180 Synthetic Implants (0.4mm x 2mm) Extend 180 Synthetic Implants 1 Pair (0.3mm x 2mm) Extend 180 Synthetic Implants 1 Pair (0.5mm x 2mm) Extend 180 Synthetic Implants (0.5mm x 2mm) Extend 180 Synthetic Implants Variety Pack Extend 180 Synthetic Implants 10 Pairs (0.3mm x 2mm) MICRO FLOW, BVI, Beaver-Visitec International Micro Flow Pre-loaded Punctal Occluder Micro Flow Punctal Occluder EdgeAhead® Sideport MVR Knife Beaver Mini-Blade® Atomic Edge® Knife Visitec® EdgeAhead® Knife Beaver Sideport MVR Knife Beaver Xstar® Knives Beaver Micro-Sharp® Blade Beaver Micro-Unitome Knife Beaver Xstar® Slit Knife Beaver Needle Blade BeaverGuard Guarded Blade Beaver Micro Knife Beaver Optimum Knife Beaver Sclerotome Blade Beaver Pocket Blade Beaver® Xstar® Safety Slit Knife Beaver® Swivel Fixation Ring 13mm Collagen Temporary Implants 0.3mm x 2mm Collagen Temporary Implants 0.4mm x 2mm Collagen Implants Variety Pack Collagen Temporary Implants 0.2mm x 2mm Malosa Core LASIK Pack 2 Malosa IVT Pack Malosa Phaco Kit Readypak Malosa Strabismus Pack Malosa Corneal Pack Malosa Core SMILE Pack Malosa Core LASIK Pack Malosa Chalazion Pack Malosa Paediatric Retinal Exam Pack Malosa IVT Dual Marker Pack Malosa Core Surface Treatment Pack Malosa Sub-Tenons Pack Malosa Core Phaco Pack Malosa Oculoplastic Suture Pack Malosa Core SMILE Pack 1 Visitec Reuable Insertion Instrument Lacrimal Probe Bowmans Probes Punctum Dilator Punctum Dilator/Lacrimal Probe Bowmans Probes, Size 00-0 Punctum Seeker Punctum Dilator, Medium Canaliculus Intubation Set (CIS) Guibor Eye Bubble Bandage Eye Patch Universal Eye Shield Left/Right Eye Shield Beaver®Tonsillectomy Blade Beaver®Cataract Blade Beaver® Neuro-Sharp Blade Beaver® Lamellar Blade Beaver® Slit Blade Beaver® Beaverguard Blade Beaver Sclerotome Blade Beaver® Debakey Blade Beaver® Micro-Blade Beaver® Sickle Edge Blade Beaver Pocket Blade Beaver Mini-Blades Ayliffe Chopper/Chopper Claw Chopper Kuglen Hook Greens Chopper Sadiq Chopper Ursell Chopper/Manipulator Corneal Ring Pocket Spreader Epithelium Hoe Denis Nucleus Chopper Vertical Y Manipulator Drysdale Manipulator Diablo Manipulator Mushroom Manipulator Epithelium Hoe Curved Button Manipulator LASIK Flap Elevator Curved Reverse Sinskey Butcher Rotator ICL Manipulator Button Tip Manipulator, (45 Degree) Horizontal Chopper/Kuglen Hook Govan Manipulator Flat Round Tip Manipulator LASIK Flap Elevator Pointed Greens Chopper, Right Handed Koch Chopper, 1.4mm, Thin Shaft Hagege Manipulator Horizontal Y Manipulator Sinskey Hook Straight Corneal Ring Pocketing Hook Phaco Chopper/Mushroom Manipulator Sinskey Hook Ball Tip Muscle Hook Seibel Nucleus Chopper Nagahara Chopper Rosen Chopper Neuhann Nucleus Divider McPherson Manipulator Diablo Chopper/Flat Button Manipulator Curved Muscle Hook Phaco Chopper Chevasse Muscle Hook Koch Chopper, 1.4mm Reverse Dialling Hook Koch Chopper 1.4mm/Button Manipulator Lester Hook Lebuisson Manipulator Kuglen Hook Angled Sinskey Hook, 0.2mm Kuglen Hook, Straight Nucleus Chopper, [P.Koch], (45 Degree) Micro Iris Hooks, [Engels], 8mm long x 8mm diameter IOL Manipulator, [Lester], .25mm IOL Manipulator, [Sinskey], Blunt tip Nucleus Rotator Plus Punctal Occluder Plus Pre-loaded Punctal Occluder Sharp Cystotome, straight Sharp Point Cystotome Blunt Tip Irrigating Cystotome Irrigating Cystotome GLAUCOMA REVISION PICK Visitec® Absorbent Stick Beaver Tympanoplasty Blade Beaver Sickle Edge Blade Peribulbar Retrobulbar BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE BVI Visidrape® Embossed Plastic Incise Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in) BVI Visidrape® Non-Woven Incise Drape with Channel Bag 140 x 127cm (55 x 50 in) BVI Visidrape® Non-Woven Incise Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in) BVI Visitec® Eye Fluid Wick, .40 x 15cm (5/32 x 5 7/8 in) BVI Visidrape® Refractive Drape Kit Aperture Drape 60 x 40cm Plain Drape 60 x 56.25cm BVI Visidrape® Full Body Incise Drape with Plastic Head and Channel Bag 165 x 254cm (65 x 100 in) BVI Visidrape® Mini Plastic Aperture Drape 41 x 41cm (16 x 16 in) BVI Visidrape® Non-Woven Full Body Aperture Drape 165 x 254cm (65 x 100 in) BVI Visitec® Mini Fluid Collection Bag with Wick, Bag: 9 x 16cm (3 ½ x 6 ¼ in) 100ml Wick: .40 x 15cm (5/32 x 5 7/8 in) BVI Visidrape® Non-Woven Full Body Incise Drape with Channel Bag 165 x 254cm (65 x 100 in) BVI Visidrape® Embossed Plastic Aperture Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in) BVI Visidrape® Non-Woven Half Body Incise Drape with Channel Bag 165 x 183cm (65 x 72 in) BVI Visitec® Microsurgical Accessory Kit BVI Visidrape® Full Body Incise Drape 140 x 244cm (55 x 96 in) BVI Visitec® Fluid Collection Bag 17 x 16cm (6 ¾ x 6 ¼ in) 250 ml BVI POUCH & WICK 100ml STX20 (Equip covers & Accessories) BVI Visidrape® Non-Woven Aperture Drape with Fluid Collection Bag 101.5 x 127cm (40 x 50 in) BVI 40x40cm PLASTIC APER STX10 BVI Visidrape® Full Body Aperture Drape 140 x 244cm (55 x 96 in) BVI Visidrape® Non-Woven Half Body Aperture Drape with Channel Bag 165 x 183cm (65 x 72 in) BVI Visitec® Ophthalmic Surgery Kit BVI Visidrape® Incise 10.2 x 20.4cm (4 x 8 in) BVI Visidrape® Dual Refractive Drape 40 x 26cm (16 x 10 ¼ in) BVI Visidrape® Non-Woven Aperture Drape with Channel Bag 140 x 127cm (55 x 50 in) BVI Visidrape® Mini Plastic Incise Drape 41 x 41cm (16 x 16 in) BVI Visidrape® SMS Incise Drape with Pre-Slit 40 x 40cm (15.75 x 15.75 in) BVI Visitec® Fluid Collection Bag with Wick, Bag: 17 x 16cm (6 ¾ x 6 ¼ in) 250ml, Wick: .40 x 15cm (5/32 x 5 7/8 in) BVI 100x127cm PLS OPHTH STX10 (drape) BVI NW INCISE STX10 (drape) BVI VISIFLEX INCISE STX10 BVI 127x140cm Aperture drape STx10 BVI 160x180cm HALF BODY STX40 (drape) BVI 40x40cm PLASTIC INC STX10 BVI Fluid collection bag 17x16cm STX20 (Equip covers & Accessories) BVI 100x127cm Aperture drape STx10 EYE DRAPE BVI POUCH & WICK 250ml STX20 E99 BVI 140x244cm FULL BODY STX10 BVI 140x244cm Aperture drape STx10 BVI 40x40cm INCISE DRAPE STX10 BVI 160x250cm FULL BODY STX40 (drape) BVI 100x127cm PLS APER STX10 (drape) BVI Dual Refractive drape STx10 LASIK Flap Separator/Elevator Epithelium Well X-Ray Pointer Eye Guard LASIK Cap / Flap Elevator, Kritzinger-Updegraff LASIK Flap Separator LASIK Flap Separator/Elevator (Seibel) Reinstein Lenticule Separato Single use instrument tray Sunalp Epithelium Well Trephining Reinstein Lenticule Separator (Hyperopic) ReLEx Pocketing Hook/Separator Birks Tying Forceps LASIK Flap Roller, [Lindstrom], 14mm Micro Retractor, Pearce, 30 degrees Chalazion Curette 2mm LASIK Flap Separator & Elevator (Binder) LASIK Flap Separator/Elevator, Curved Epithelium Well, 8.5mm LASEK Microhoe, (Yee), Formed tip, 12mm from end Corneal Epithelium Spatula, Flat Punctum Dilator/Seeker Fine Toothed Forceps Short (Bonn) Straight Tying Forceps Short Barraquer Speculum, Solid 18mm Blade (PC) LASIK Flap Elevator, Curved, 8mm Jewellers Forceps Curved/Plain Punctum Plug Forceps LASIK Flap-Lifting Forceps Iris Scissors Straight, Pointed LASIK Flap Separator/Elevator Straight Toothed Forceps (Bonn) IOL Removal Forceps Malosa® Neonatal Speculum LASIK Flap Separator, Flattened Tip Deluxe Patient Pack Standard Patient Pack CustomEyes®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2016-11-30
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2010-08-11
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2025-01-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-05-20
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2010-08-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-08-12
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2017-11-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2021-05-18
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2010-08-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-08-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-08-11
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2010-08-11
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-11-29
JYO	Knife, Ear	Ear, Nose, Throat	Class 1	874.4420	2021-11-24
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2013-07-23
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-03-10
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2012-08-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2012-12-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-08-11

Official Correspondent

No official correspondent registered.

US Agent Details

Silvana Brown Business: Beaver-Visitec International, Inc. Email: regulatory@bvimedical.com Phone: (952) 7377242

Related Public Records

Same Entity

Beaver-Visitec International, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3012539515	Rio Bravo International Inc	El Paso, TX, US
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2247224	Beaver-Visitec International, Inc	Little Silver, NJ, US
3013466775	Grupo American Industries, S.A. de C.V	Ciudad Juarez Chihuahua, MX
9680620	Beaver-Visitec International, Ltd	BIDFORD-ON-AVON Warwickshire, GB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013421458. Last updated year: 2026. Please use registration number 3013421458 when referencing this establishment in official correspondence.