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) (7) Brush, Haidinger, (Including Macular Integrity) (HIY) (2) Forceps, Ophthalmic (HNR) (1)

Premarket Exempt

Yes

Clear

Rumex - 00840159900116 Catalog Number : 7-080/SIM

Device Description : Simcoe I/A Tip , Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900123 Catalog Number : 7-0813

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 0.50 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 - 00840159900130 Catalog Number : 12-6000

Device Description : Titanium Backflush, Active Aspiration, Length 118 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900147 Catalog Number : 12-6010

Device Description : Titanium Backflush, Passive Aspiration, Length 108 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900154 Catalog Number : 7-0811

Device Description : Stodulka Enhanced Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Tw Stodulka Enhanced Irrigation Handpiece For Bimanual Technique, Curved, 21 Ga, Two Ports On Side 0.50 x 1.00 mm, Length 105 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900161 Catalog Number : 13-139/I

Device Description : Endothelial Stripper, Irrigating, For Descemet’s Stripping, Length 104 mm, Tita Endothelial Stripper, Irrigating, For Descemet’s Stripping, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900178 Catalog Number : 7-0826

Device Description : Aspiration Handpiece, 23 Ga, 1.00 X 0.30 mm Port, Polished Ball Tip, Curved, Len Aspiration Handpiece, 23 Ga, 1.00 X 0.30 mm Port, Polished Ball Tip, Curved, Length 104 mm, Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : KYG

Prescription Use : No

Device Count : 1

Rumex - 00840159900208 Catalog Number : 16-140

Device Description : Alger Brush Rust Ring Remover With 1.00 mm Burr, Length 105 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HIY

Prescription Use : No

Device Count : 1

Rumex - 00840159900215 Catalog Number : 16-141

Device Description : Alger Brush Rust Ring Remover With 0.50 mm Burr, Length 105 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HIY

Prescription Use : No

Device Count : 1

Rumex - 00840159900222 Catalog Number : 12-410-23

Device Description : Eckardt End Gripping Vitreoretinal Forceps, 23 Ga, Tip Only

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

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