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

Specula, Ophthalmic (HNC) (4) Scissors, Ophthalmic (HNF) (2) Tray, Surgical, Instrument (FSM) (2) Forceps, Ophthalmic (HNR) (1) Hook, Ophthalmic (HNQ) (1)

Premarket Exempt

Yes

Clear

Rumex - 00840159900338 Catalog Number : 11-052S

Device Description : Vannas Capsulotomy Scissors, Curved, Sharp Tips, 6.00 mm Blades, Flat Handle, Le Vannas Capsulotomy Scissors, Curved, Sharp Tips, 6.00 mm Blades, Flat Handle, Length 84 mm, Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNF

Prescription Use : No

Device Count : 1

Rumex - 00840159900345 Catalog Number : 18-304

Device Description : Plastic Sterilizing Tray With Silicone Finger Mat, Extra Large, 254.00 x 152.00 x 19.00 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Rumex - 00840159900352 Catalog Number : 5-032

Device Description : Sinskey Hook, Angled, 0.15mm x 10.00 mm Shaft, Length 122mm, Round Titanium Handle

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNQ

Prescription Use : No

Device Count : 1

Rumex - 00840159900369 Catalog Number : 4-0321T

Device Description : Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Flat Handle, Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Flat Handle, Length 107 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900376 Catalog Number : 14-040T

Device Description : Lieberman Temporal Speculum, Rounded "V" Shaped Blades, Adult Size, Length 71 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : No

Device Count : 1

Rumex - 00840159900383 Catalog Number : 14-040S

Device Description : Lieberman Temporal Speculum, Rounded "V" Shaped Blades, Adult Size, Length 71 mm Lieberman Temporal Speculum, Rounded "V" Shaped Blades, Adult Size, Length 71 mm, Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : No

Device Count : 1

Rumex - 00840159900390 Catalog Number : 14-0102S

Device Description : Eye Speculum with Rachet lock, 15.00 mm Fenestrated Blades, Overall Length 70 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : No

Device Count : 1

Rumex - 00840159900406 Catalog Number : 18-305

Device Description : Plastic Sterilizing Tray With Silicone Finger Mat, Double Level, Extra Large, 25 Plastic Sterilizing Tray With Silicone Finger Mat, Double Level, Extra Large, 254.00 x 152.00 x 38.00 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Rumex - 00840159900420 Catalog Number : 11-044S

Device Description : Westcott Stitch Scissors, Sharp Tips, 16.00 mm Blades, Flat Handle, Length 120 m Westcott Stitch Scissors, Sharp Tips, 16.00 mm Blades, Flat Handle, Length 120 mm, Stainless Steel

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNF

Prescription Use : No

Device Count : 1

Rumex - 00840159900437 Catalog Number : 14-040TK

Device Description : Lieberman Temporal Speculum, Rounded Kratz Style Blades, Adult Size, Length 71 m Lieberman Temporal Speculum, Rounded Kratz Style Blades, Adult Size, Length 71 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNC

Prescription Use : No

Device Count : 1

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