IEC-Innoview GmbH 30-0514-00

GUDID B192300514000

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

INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Rigid ureteroscope Rigid ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope

• Primary Device ID: B192300514000
• NIH Device Record Key: 31776827-e51a-4a70-a31c-decd9b23d05e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IEC-Innoview GmbH
• Version Model Number: 30-0514-00
• Catalog Number: 30-0514-00
• Company DUNS: 010741028
• Company Name: INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French
• Catheter Gauge: 7.5 French
• Length: 430 Millimeter
• Angle: 12 degree
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B192300514000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062707

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

[B192300514000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-26

On-Brand Devices [IEC-Innoview GmbH]

• B192300646000: Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 5 deg., direct/straight view, L=430 mm, autoclavable
• B192300515000: 4 mm, 30deg. Cystoscope, autoclavable, L=302 mm, F.O.V. 70deg.
• B192300514000: Semi-rigid Uretero Renoscope 6.0/7.5 Fr. 12deg., Lateral offset Eyepiece (Marberger), L=430 mm,
• B192300495000: 5 mm, 30 deg Laparoscope, L=300 mm, autoclavable, Large View
• B192300494000: 5 mm, 0 deg Laparoscope, L=300 mm, autoclavable, Large View
• B192300428000: 10 mm, 30 deg Laparoscope, L=339 mm, autoclavable, Laser welded
• B192300427000: 10 mm, 0 deg Laparoscope, L=339 mm, autoclavable, Laser welded
• B192300421000: 4.0 mm, 30 deg. Cystoscope, l=281.50mm, autoclavable, Olympus Compatible
• B192300401000: Bariatric 10 mm, 45 deg Laparoscope, L=425 mm, autoclavable
• B192300348000: 2.9 mm, 30 deg. Cystoscope, l=302mm, autoclavable
• B192300346000: 2.9 mm, 0 deg. Cystoscope, l=302mm, autoclavable
• B192300311000: 4.0 mm, 45 deg. Sinuscope, l=175mm, autoclavable
• B192300083000: 10.0 mm, 30 deg. Thoracoscope, l=170mm, autoclavable
• B192300068000: Semi-rigid Uretero Renoscope 7.5 / 8.5 Fr. 12 deg., Lateral offset Eyepiece (Marberger), L=430 m
• B192300057000: 4.0 mm, 30 deg. Cystoscope, l=302mm, autoclavable ( Cysto sheath ONLY-NOT Resectoscope/Working E
• B192300055000: 4.0 mm, 0 deg. Cystoscope, l=302mm, autoclavable
• B192300054000: 2.7 mm, 30 deg. Cystoscope, l=302mm, autoclavable
• B192300043000: 4.0 mm, 0 deg. Otoscope, l=50mm, autoclavable
• B192300012000: 4.0 mm, 70 deg. Arthroscope, l=175mm, autoclavable
• B192300011000: 4.0 mm, 30 deg. Arthroscope, l=175mm, autoclavable
• B192300010000: 4.0 mm, 0 deg. Arthroscope, l=175mm, autoclavable
• B192300008000: 2.7 mm, 30 deg. Arthroscope, l=187.5mm, autoclavable
• B192300006000: 2.7 mm, 70 deg. Arthroscope, l=175mm, autoclavable
• B192300004000: 2.7 mm, 0 deg. Arthroscope, l=175mm, autoclavable
• B192300003000: 2.7 mm, 70 deg. Arthroscope, l=110mm, autoclavable
• B192300278000: 8 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable
• B192300049000: 10 mm, 90 deg. Laryngoscope, l=190 mm, autoclavable
• B192300048000: 10 mm, 70 deg. Laryngoscope, l=190 mm, autoclavable