UVISION 360, INC.

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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

Cystoscope And Accessories, Flexible/Rigid (FAJ) (9) Hysteroscope (And Accessories) (HIH) (9) Aspirator, Endometrial (HFF) (2) Instrument, Biopsy, Suction (FCK) (2)

Premarket Exempt

Clear

LUMINELLE DTx 360 Rotatable Disposable Sheaths - 00853277008008 Catalog Number : 20020

Device Class :

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

Uvision Hysteroscope - 00853277008015 Catalog Number : 20010

Device Class : 2

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

Uvision Hysteroscope Cable - 00853277008022 Catalog Number :

Device Class :

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : No

Device Count : 1

Luminelle DTx Control Hub - 00853277008039 Catalog Number :

Device Class : 2

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : No

Device Count : 1

LUMINELLE DTx Hysteroscopy System - 00853277008046 Catalog Number : 20030

Device Description : Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit dir Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Class : 2

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ

Prescription Use : Yes

Device Count : 1

LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath - 00853277008053 Catalog Number : 20060

Device Class : 2

Duns Number: 080826327

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic) - 00853277008060 Catalog Number : 20070

Device Description : The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Dispo The LUMINELLE DTx Hysteroscopy System with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic).

Device Class :

Duns Number: 080826327

Premarket Exempt : No

Product Code : FAJ, HIH

Prescription Use : Yes

Device Count : 1

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) - 00853277008084 Catalog Number : 20080

Device Description : LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

Device Class :

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ, HFF, FCK

Prescription Use : Yes

Device Count : 1

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) - 00853277008091 Catalog Number : 20085

Device Description : LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

Device Class :

Duns Number: 080826327

Premarket Exempt : No

Product Code : HIH, FAJ, HFF, FCK

Prescription Use : Yes

Device Count : 1

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