ENGINEERED MEDICAL SOLUTIONS COMPANY, L.L.C.

Address:85 INDUSTRIAL DRIVE,Phillipsburg,NJ,08865,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

Lamp, Surgical (FTD) (6) Light, Surgical, Accessories (FTA) (4) Catheter And Tip, Suction (JOL) (1) Instrument, Manual, Surgical, General Use (MDM) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

SurgiLight Adapter - AIM-100 - 10850009233018 Catalog Number :

Device Description : An adapter used specifically to secure the View Medical SurgiLight to the light

Device Class : 2

Duns Number: 828549936

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : Yes

Device Count : 1

SurgiLight Adapter - Skytron - 10865082000105 Catalog Number :

Device Description : An adapter used specifically to secure the View Medical SurgiLight to the light

Device Class : 2

Duns Number: 828549936

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : Yes

Device Count : 1

Scintillant - 10865082000112 Catalog Number :

Device Description : Scintillant Surgical Light with Zip Strap

Device Class : 2

Duns Number: 828549936

Premarket Exempt : No

Product Code : FTD

Prescription Use : No

Device Count : 1

Scintillant - 10865082000129 Catalog Number :

Device Description : Scintillant Surgical Light with Suction

Device Class : 2

Duns Number: 828549936

Premarket Exempt : No

Product Code : JOL, FTD

Prescription Use : No

Device Count : 1

Scintillant - 10865082000136 Catalog Number :

Device Description : Scintillant Surgical Light with Retractor

Device Class : 1

Duns Number: 828549936

Premarket Exempt : No

Product Code : GAD, FTD

Prescription Use : No

Device Count : 1

Scintillant - 10865082000143 Catalog Number :

Device Description : Scintillant Dual Bent Tip Surgical Light

Device Class : 2

Duns Number: 828549936

Premarket Exempt : No

Product Code : FTD

Prescription Use : No

Device Count : 1

Scintillant - 10865082000150 Catalog Number :

Device Description : Scintillant Dual Straight Tip Surgical Light

Device Class : 2

Duns Number: 828549936

Premarket Exempt : No

Product Code : FTD

Prescription Use : No

Device Count : 1

Safe-T-Surg - 10865082000167 Catalog Number :

Device Description : Safe-T-Surg Retractor

Device Class :

Duns Number: 828549936

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 2

SurgiLight Disposable Handle Assembly - 10865082000174 Catalog Number :

Device Description : The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight.

Device Class : 2

Duns Number: 828549936

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : Yes

Device Count : 1

View Medical SurgiLight - 10865082000181 Catalog Number :

Device Description : The SurgiLight by View Medical is a surgical lighting system that aims to provid

Device Class : 2

Duns Number: 828549936

Premarket Exempt : Yes

Product Code : FTA, FTD

Prescription Use : Yes

Device Count : 1

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