RUMEX INTERNATIONAL CORP.

Address:14240 Carlson Circle, Building K, Suite 8,Tampa,FL,33626,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Irrigation, Ocular Surgery (KYG) (8) Scissors, Ophthalmic (HNF) (2)

Premarket Exempt

Yes

Clear

Rumex - 00840159900017 Catalog Number : 11-134S

Device Description : Holland Spatulated DALK Scissors, Right, Micro blades, Delicate Shortened Outer Holland Spatulated DALK Scissors, Right, Micro blades, Delicate Shortened Outer Blade Rounded Blunt Tips, Length 100 mm, Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNF

Prescription Use : No

Device Count : 1

Rumex - 00840159900024 Catalog Number : 11-135S

Device Description : Holland Spatulated DALK Scissors,Left, Micro blades, Delicate Shortened Outer Bl Holland Spatulated DALK Scissors,Left, Micro blades, Delicate Shortened Outer Blade Rounded Blunt Tips, Length 100 mm, Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNF

Prescription Use : No

Device Count : 1

Rumex - 00840159900031 Catalog Number : 12-003T

Device Description : Vitreoretinal Instrument Handle, Squeeze Model, Two Fingers Control, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900048 Catalog Number : 7-0821-23

Device Description : Aspiration Handpiece For Bimanual Technique, Curved, 23 Ga, One Top Port 0.30 mm Aspiration Handpiece For Bimanual Technique, Curved, 23 Ga, One Top Port 0.30 mm, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900055 Catalog Number : 7-081-23

Device Description : Irrigation Handpiece For Bimanual Technique, Curved, 23 Ga, Two Ports On Side 0. Irrigation Handpiece For Bimanual Technique, Curved, 23 Ga, Two Ports On Side 0.35 mm, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900062 Catalog Number : 7-081

Device Description : Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0. Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0.35mm, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900079 Catalog Number : 12-001T

Device Description : Vitreoretinal Instrument Handle, One Finger Control, Length 108 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900086 Catalog Number : 7-082

Device Description : Aspiration Handpiece For Bimanual Technique, Curved, 21 Ga, One Top Port 0.35mm, Aspiration Handpiece For Bimanual Technique, Curved, 21 Ga, One Top Port 0.35mm, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900093 Catalog Number : 7-0821

Device Description : Aspiration Handpiece For Bimanual Technique, Curved, 22 Ga, One Top Port 0.35mm, Aspiration Handpiece For Bimanual Technique, Curved, 22 Ga, One Top Port 0.35mm, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900109 Catalog Number : 7-080/IAH

Device Description : Irrigation-Aspiration Handpiece, Standard connectors, Round Handle, Length 110 m Irrigation-Aspiration Handpiece, Standard connectors, Round Handle, Length 110 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

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