INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Address:320 International Pkwy,Sunrise,FL,33325,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

Laparoscope, Gynecologic (And Accessories) (HET) (2) Ureteroscope And Accessories, Flexible/Rigid (FGB) (2) Cystoscope And Accessories, Flexible/Rigid (FAJ) (1)

Premarket Exempt

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IEC-Innoview GmbH - B192300494000 Catalog Number : 30-0494-00

Device Description : 5 mm, 0 deg Laparoscope, L=300 mm, autoclavable, Large View

Device Class : 2

Duns Number: 010741028

Premarket Exempt : No

Product Code : HET

Prescription Use : No

Device Count : 1

IEC-Innoview GmbH - B192300495000 Catalog Number : 30-0495-00

Device Description : 5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View

Device Class : 2

Duns Number: 010741028

Premarket Exempt : No

Product Code : HET

Prescription Use : No

Device Count : 1

IEC-Innoview GmbH - B192300514000 Catalog Number : 30-0514-00

Device Description : Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 12deg., Lateral offset Eyepiece (Marber Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 12deg., Lateral offset Eyepiece (Marberger), L=430 mm, autoclavable

Device Class : 2

Duns Number: 010741028

Premarket Exempt : No

Product Code : FGB

Prescription Use : No

Device Count : 1

IEC-Innoview GmbH - B192300515000 Catalog Number : 30-0515-00

Device Description : 4 mm, 30deg. Cystoscope, autoclavable, L=302 mm, F.O.V. 70deg.

Device Class : 2

Duns Number: 010741028

Premarket Exempt : No

Product Code : FAJ

Prescription Use : No

Device Count : 1

IEC-Innoview GmbH - B192300646000 Catalog Number : 30-0646-00

Device Description : Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable

Device Class : 2

Duns Number: 010741028

Premarket Exempt : No

Product Code : FGB

Prescription Use : No

Device Count : 1

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