Surgilum, LLC

Address:2 North Front Street,Wilmington,NC,28401,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

Marker, Ocular (HMR) (5)

Premarket Exempt

Yes

Clear

Surgilum - B836IRT1010 Catalog Number : IRT101

Device Description : A sterile device intended to be fitted to the RoboMarker (corneal marker) handpi A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. this is a single-use device.

Device Class :

Duns Number: 079726409

Premarket Exempt : Yes

Product Code : HMR

Prescription Use : No

Device Count : 1

Surgilum - B836RMS1010 Catalog Number : RMS101

Device Description : A manually-operated instrument intended to be used with a disposable handpiece t A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it includes a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.

Device Class : 1

Duns Number: 079726409

Premarket Exempt : Yes

Product Code : HMR

Prescription Use : No

Device Count : 1

RoboMarker G2 - B836RMSG2 Catalog Number : RMSG2

Device Description : A manually-operated instrument intended to be used with a disposable handpiece t A manually-operated instrument intended to be used with a disposable handpiece tip (no included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-leveling mechanism intended to accept the ink-loaded tip; it include a battery powered fixation light intended to draw the patient's focus and a projected laser target to assist with accuracy during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.

Device Class : 1

Duns Number: 079726409

Premarket Exempt : Yes

Product Code : HMR

Prescription Use : No

Device Count : 1

Surgilum - B836TPS1010 Catalog Number : TPS101

Device Description : A sterile device intended to be fitted to the RoboMarker (corneal marker) handpi A sterile device intended to be fitted to the RoboMarker (corneal marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a small device preloaded with ink. This is a single-use device.

Device Class :

Duns Number: 079726409

Premarket Exempt : Yes

Product Code : HMR

Prescription Use : No

Device Count : 1

RoboTip G2 - B836TPSG2 Catalog Number : TPSG2

Device Description : A sterile device intended to be fitted to the RoboMarker G2 (Corneal Marker) han A sterile device intended to be fitted to the RoboMarker G2 (Corneal Marker) handpiece to directly ink mark corneal tissue prior to an ophthalmic surgical procedure that can be seen under infrared lighting. It is a small device preloaded with ink. This is a single-use, sterile device.

Device Class : 1

Duns Number: 079726409

Premarket Exempt : Yes

Product Code : HMR

Prescription Use : No

Device Count : 1

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