RUMEX INTERNATIONAL CORP.

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

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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

Forceps, Ophthalmic (HNR) (6) Holder, Needle, Gastroenterologic (FHQ) (3) Scissors, Ophthalmic (HNF) (1)

Premarket Exempt

Yes

Clear

Rumex - 00840159900543 Catalog Number : 4-0395

Device Description : Capsulorhexis Forceps With SCALE (2.50 mm, 5.00 mm From The Tip), Cross Action, Capsulorhexis Forceps With SCALE (2.50 mm, 5.00 mm From The Tip), Cross Action, Curved Stainless Steel Jaws 8.50 mm, For 1.50 mm Incisions, Flat Titanium Handle, Length 100 mm

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900550 Catalog Number : 4-2150

Device Description : Rowen Rescue Kit For Foldable Lens Removal, Crocodile Type Forceps, 20 Ga, Tip Only

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900567 Catalog Number : 4-0331T

Device Description : Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Round Handle Utrata Capsulorhexis Forceps, Cystotome Tips, Curved 11.00 mm Jaws, Round Handle, Length 110 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900574 Catalog Number : 4-050T

Device Description : Colibri Corneal Forceps, 0.12 mm, 1x2 Teeth, Flat Handle, Length 84 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900581 Catalog Number : 8-031T

Device Description : Barraquer Needle Holder, Standard Jaws 12.00 mm, Curved With Out Lock, Medium Si Barraquer Needle Holder, Standard Jaws 12.00 mm, Curved With Out Lock, Medium Size, Length 115 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Rumex - 00840159900598 Catalog Number : 8-041T

Device Description : Barraquer Needle Holder, Fine Jaws 12.00 mm, Curved Without Lock, Medium Size, L Barraquer Needle Holder, Fine Jaws 12.00 mm, Curved Without Lock, Medium Size, Length 115 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Rumex - 00840159900611 Catalog Number : 8-045T

Device Description : Barraquer Needle Holder, Extra Fine Jaws 8.00 mm, Curved With Out Lock, Medium S Barraquer Needle Holder, Extra Fine Jaws 8.00 mm, Curved With Out Lock, Medium Size, Length 115 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : FHQ

Prescription Use : No

Device Count : 1

Rumex - 00840159900628 Catalog Number : 11-042S

Device Description : Westcott Curved Tenotomy Scissors, Blunt Tips, 16.00 mm Blades, Flat Handle, Len Westcott Curved Tenotomy Scissors, Blunt 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 - 00840159900635 Catalog Number : 4-0501T

Device Description : Colibri Corneal Forceps, 0.12 mm, 1x2 Teeth, Flat Handle, Length 77 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

Rumex - 00840159900642 Catalog Number : 4-058T

Device Description : Bonn Corneal Forceps, Straight, 0.12 mm, 1x2 Teeth, Medium Size, Flat Handle, Le Bonn Corneal Forceps, Straight, 0.12 mm, 1x2 Teeth, Medium Size, Flat Handle, Length 94 mm, Titanium

Device Class : 1

Duns Number: 041546137

Premarket Exempt : Yes

Product Code : HNR

Prescription Use : No

Device Count : 1

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