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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Argon Medical Scalpels; BEAVER ARTHRO-LOK BANANA 4MM BLADE; BEAVER ARTHRO-LOK HOE 60 4MM BLADE; BEAVER ARTHRO-LOK MINI-BANANA 4MM BLADE; BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE; BEAVER ARTHRO-LOK MINI-MENISCUS 4MM BLADE (FLAT); BEAVER ARTHRO-LOK POINTED RETROGRADE 4MM BLADE; BEAVER ARTHRO-LOK POINTED TIP CURVE L 4MM BLADE; BEAVER ARTHRO-LOK RETROGRADE 4MM BLADE; BEAVER ARTHRO-LOK ROSETTE 4MM BLADE; BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE; BEAVER ARTHRO-LOK ROUNDED TIP 4MM BLADE (FLAT); BEAVER BEAVERGUARD GUARDED .35MM DEPTH BLADE; BEAVER BEAVERGUARD GUARDED .50MM DEPTH BLADE; BEAVER BENT BLADES 45 SHARP ALL AROUND; BEAVER BLADE; BEAVER CATARACT BLADE 19.0MM L X 1.4MM W; BEAVER CATARACT BLADE 20.5MM L X 1.7MM W; BEAVER CATARACT BLADE 25.5MM L X 2.2MM W; BEAVER CERVICAL BIOPSY BLADE; BEAVER MICRO-BLADE 15; BEAVER MICRO-BLADE 30; BEAVER MINI-BANANA BLADE (FLAT) 4MM; BEAVER MINI-BLADE SURGICAL BLADE 180; BEAVER NEEDLE BLADE 1.5MM CUTTING EDGE; BEAVER NEEDLE BLADE 3.0MM CUTTING EDGE; BEAVER NEEDLE BLADE 5.0MM CUTTING EDGE; BEAVER NEEDLE BLADE 7.0MM CUTTING EDGE; BEAVER OPTIMUM BLADE 15 STRAIGHT; BEAVER OPTIMUM BLADE 22.5 STRAIGHT; BEAVER OPTIMUM BLADE 30 STRAIGHT; BEAVER OPTIMUM BLADE 45 STRAIGHT; BEAVER POCKET BLADE 2.25MM W 60 BEVEL UP; BEAVER POCKET BLADE 3.0MM W 60 BEVEL DOWN; BEAVER POCKET CRESCENT BLADE 2.5MM 55 BEVERL UP; BEAVER POCKET SCLERAL KNIFE 2.25MM 60; BEAVER POCKET SCLERAL KNIFE 3.0MM 60; BEAVER SCLEROTOME BLADE MULTI-SIDED; BEAVER SCLEROTOME KNIFE SHARP ALL AROUND; BEAVER SICKLE EDGE BLADE 5.0MM; BEAVER SLIT BLADE 1.5MM STRAIGHT; BEAVER SLIT BLADE 2.8MM 45 BEVEL DOWN; BEAVER SLIT BLADE 3.0MM 45 BEVEL DOWN; BEAVER SLIT BLADE 3.0MM 45 BEVEL UP; BEAVER SLIT BLADE 3.0MM STRAIGHT; BEAVER SLIT BLADE 3.2MM 45 BEVEL DOWN; BEAVER TYMPANOPLASTY BLADE 2.0MM W 50 BEVEL DOWN; BEAVER TYMPANOPLASTY BLADE 2.5MM W 60 BEVEL DOWN; BEAVER TYMPANOPLASTY BLADE 2.5MM W STRAIGHT; Blade, Scalpel; DermaBlade; DermaPlane; Dermaplane 10S bladkes; Lumohs Loader; Lumohs Scalpel; Safety Cartridge #10 Carbon Steel Blade Purple Cartridge; Safety Cartridge #10 Stainless Steel Blade Green Cartridge; Safety Cartridge #11 Carbon Steel Blade Orange Cartridge; Safety Cartridge #11 Stainless Steel Blade Blue Cartridge; Safety Cartridge #15 Carbon Steel Blade Red Cartridge; Safety Cartridge #15 Stainless Steel Blade Yellow Cartridge; Safety scalpel; Scalpel Blades; Short/Long Handle Scalpels; Single Use #10 Safety Scalpel; Single Use #11 Safety Scalpel; Single Use #15 Safety Scalpel; Surgical 10 blades; Surgical 11 blades; Surgical 15 blades
Classification Name: BLADE, SCALPEL
Product Code: GES
Device Class: 1
Regulation Number: 878.4800
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Sterigenics US LLC
Registered Establishment Number: 1058584
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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