LUMITEX, INC.

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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

Retractor, Fiberoptic (FDG) (9) Unit, Neonatal Phototherapy (LBI) (1)

Premarket Exempt

No Yes

Clear

Bilisoft 2.0 - 00812432020484 Catalog Number :

Device Description : The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

Device Class : 2

Duns Number: 108631797

Premarket Exempt : No

Product Code : LBI

Prescription Use : Yes

Device Count : 1

Zimmer Biomet - AccuVision Blade Tip - 22mm - 00812432020507 Catalog Number : 14-500552

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Zimmer Biomet - AccuVision Blad 25mm Flat - 00812432020514 Catalog Number : 14-500551

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Zimmer Biomet - Accuvision Blade Tip - 18mm - 00812432020521 Catalog Number : 14-500550

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Zimmer Biomet - AccuVision Blade 25mm x .33 - 00812432020538 Catalog Number : 14-500557

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Zimmer Biomet - AccuVision Blade 25mm Flat Illuminated - 00812432020545 Catalog Number : 14-500556

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Zimmer Biomet - AccuVision Blad 18mm x .33 Illuminated - 00812432020552 Catalog Number : 14-500555

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Fiber Optic Cable - 00812432020569 Catalog Number : 48250215

Device Description : The LightMat Surgical Illuminator product family are supplied as sterile or non- The LightMat Surgical Illuminator product family are supplied as sterile or non-sterile, single use, latex free, plastic fiber optic devices intended to bring cool area lighting into deep surgical sites. The LightMat is typically attached to various surgical retractors though use of adhesive strips and/or pre-applied adhesive backing. Some models of the LightMat also contain internal malleable members to provide moderate blunt retraction on its own.

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

SeaSpine Surgical Illuminator Cable - 00812432020675 Catalog Number : 91-8408

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

K2M - NIAGARA Lateral Access System Bifurcated Illuminator - 00812432020682 Catalog Number : AC01-90046

Device Class : 1

Duns Number: 108631797

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

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