Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013466775

FEI Number

3013466775

Entity Name

Grupo American Industries, S.A. de C.V

City/State/Country

Ciudad Juarez Chihuahua, MX

Establishment Address

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

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

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

K013613

PMA Number

N/A

All Registered Proprietary Names

Beaver Visitec International Beaver, BVI Beaver Visitec International Beaver® Myringotomy Blade Upcutting Tip, 45 Degree Beaver® Spear Tip Myringotomy Knife 45 Degree Beaver® Myringotomy Blade Downcutting Tip 45 Degree Beaver® Tympanoplasty Blade, 2.5mm W, 60 Degree Bevel Down Beaver® Tympanoplasty Blade, 2.5mm W Straight Beaver® Myringotomy Knife, Lance Tip 45 Degree Beaver® Myringotomy Blade, Offset 45 Degree IOL Removal Forceps 45 Degree Toothed Forceps Sclerectomy Forceps Thornton Fixation Ring Fine Stem Toothed Forceps Max Fine Micro-Corneal Forceps Fine Toothed Forceps Iris Pointed Forceps Iris Fine Toothed Forceps Fixation Ring Jewellers Forceps Contact Lens Forceps Moorfields Forceps Corneal Ring Forceps - Keraring Bishops Forceps Lens Folding Forceps Straight Rampley Scleral Plug Forceps Lenticule Extraction Forceps Kocaba DMEK Forceps Single Use Instrument, Bonn Forceps MICS Capsulorhexis - Straight/Sharp Crocodile Forceps Halstead Mosquito Jewellers Forceps Angled Micro Cross-Action Bulldog Clamp Angled Tying Forceps (McPherson) Epilation Forceps Jewellers Forceps, Fine Angled Curved Tying Forceps Capsulorhexis Forceps Toothed Forceps Birks Tying Forceps IOL Implantation Forceps Straight Tying Forceps, Short Straight Tying Forceps Catford Forceps Jewellers Forceps, Fine Straight Colibri Toothed Forceps St Martins Forceps Backhaus Towel Clip Meibomian Gland Forceps Kelly Forceps Punctum Plug Forceps Adson Forceps Toothed LASIK Flap-Lifting Forceps Colibri Notched Forceps Toothed Forceps (Bonn) Spencer Wells Artery Forceps Waqar Suture Removal Forceps Waughs Dissecting Forceps Fine Notched Forceps Short (Hoskins) MICS Capsulorhexis MICS Capsulorhexis - Straight/Blunt Colibri Toothed Forceps, Short Adson Forceps Non-Toothed Lens Loading Forceps Jayles Forceps Iris Pointed Forceps, 105mm Notched Forceps (Hoskins) Clip - Long Handled Forceps (Pair) Barron Scalpel Handle Flat Beaver Blade Wrench Dynagrip Handle and Wrench 4mm Artho-Lok Handle and Wrench 4mm Beaver Handle (Round Knurled Stainless) Beaver BeaverTail Flat Handle Lens Handle Scalpel Blade Handle With Gradations Beaver Handle Beaver Replacement Chuck Collet Visitec® Absorbent Stick Guibor Eye Bubble Bandage Eye Patch Universal Eye Shield Left/Right Eye Shield BVI Maxi-Lite Diagnostic Penlight BVI Nurse-Mate Six Pack Diagnostic Penlight BVI Blu-Spot® Diagnostic Penlight BVI Doctor's Six Pack Diagnostic Penlight CustomEyes® Infant Speculum Wire Eye Speculum Clarke Speculum Kratz-Barraquer Cook Neonatal Speculum Barrett Speculum Mechanical Speculum Paediatric Speculum Pierce Adjustable Speculum Corcelle Speculum Solid Blade Sauer Neonatal Speculum Kratz-Barraquer Speculum, Curved Neonatal Speculum Paediatric Mechanical Speculum Single use instrument tray Dr. Sunalp Barraquer Speculum Alphonso Paediatric Speculum IOL Manipulator, Jaffe - Maltzman, Blunt tip 45 degree Kratz-Barraquer Speculum Kratz-Barraquer Speculum, Temporal Barraquer Speculum, Solid Blade (PC) Barraquer Speculum, Flat Blade Mechanical Speculum, Open Blade (PC) Parasol® Pre-Loaded Punctal Occluder Medium 0.6mm 0.85mm Parasol® Quickload Punctal Occluder Large 0.9mm+ Parasol® Pre-Loaded Punctal Occluder Small 0.35mm 0.65mm Parasol® Punctal Occluder Bulk NS Large 0.9mm+ Parasol® Pre-Loaded Punctal Occluder Large 0.9mm+ Parasol® Quickload Punctal Occluder Combo Pack Small Medium Parasol® Quickload Punctal Occluder Small 0.35mm 0.65mm Parasol® Punctal Occluder Bulk NS Small 0.35-0.65mm Parasol® Quickload Punctal Occluder Medium 0.6mm 0.85mm Parasol® Pre-Loaded Punctal Occluder X-Small 0.25mm 0.35mm Parasol® Punctal Occluder Bulk NS Medium 0.6-0.85mm Parasol® Punctal Occluder Bulk NS Combo Small/Medium Visitec® Irrigation Handle Visitec® Single Fluid Administration Set Visitec® Double Male Luer Visitec® High Flow Filter Beaver Ring Cutter Hub Beaver Ring Cutter Beaver Ring Cutter Saw Blade Beaver Ring Cutter Washer 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 Merocel Diamond Cleaning Block I-Ring® Pupil Expander Beaver® Swivel Fixation Ring Sharp Cystotome, straight Sharp Point Cystotome Blunt Tip Irrigating Cystotome Irrigating Cystotome GLAUCOMA REVISION PICK Plus Punctal Occluder Plus Pre-loaded Punctal Occluder Accu-Temp High Temperature Cautery Handle Accu-Temp Interchangeable Fine Tip Accu-Temp Low Temperature Cautery Handle Accu-Temp Interchangeable Loop Tip 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 MICRO FLOW, BVI, Beaver-Visitec International Micro Flow Pre-loaded Punctal Occluder Micro Flow Punctal Occluder 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) Y Shape Corneal Marker Horizontal Axis Marker Toric Marker Double-Ring Corneal Marker Visitec® Visimark Corneal Marking Pad Mendez Gauge S Marker 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 Beaver Myringotomy Blade Beaver Myringotomy Knife 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 Extend Synthetic Implants (0.5mm x 2mm) Extend Synthetic Implants (0.4mm x 2mm) Extend Synthetic Implants (0.3mm x 2mm) Extend Synthetic Implants (Variety Pack) Extend Synthetic Implants (0.2mm x 2mm)

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
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-08-11
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-11
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2010-08-11
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-11-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2010-08-11
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2010-08-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-08-11
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-08-10
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2010-08-11
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2010-08-11
PZG	Surgical Eye Tray	Ophthalmic	Class 1	886.4350	2021-05-18
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2011-05-20
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2010-08-11
HNY	Cystotome	Ophthalmic	Class 1	886.4350	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2014-06-17
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-03-10
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2017-11-08
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2010-08-11
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2021-11-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-08-12
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-24
LZU	Plug, Punctum	Unknown	Class U	N/A	2013-04-11

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

Registration Number	Establishment Name	Location
3012539515	Rio Bravo International Inc	El Paso, TX, US
3012733432	Malosa Medical Instruments (Changshu) Limited	Changshu Jiangsu, CN
2247224	Beaver-Visitec International, Inc	Little Silver, NJ, US
3013421458	Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, MX
9680620	Beaver-Visitec International, Ltd	BIDFORD-ON-AVON Warwickshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K961683	J.J. Skinner, Inc.	JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY	1996-05-10
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013466775. Last updated year: 2026. Please use registration number 3013466775 when referencing this establishment in official correspondence.