IEC-Innoview GmbH 30-0494-00

GUDID B192300494000

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

INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C.

Rigid optical laparoscope

• Primary Device ID: B192300494000
• NIH Device Record Key: c74f7353-1084-4aa2-851e-3377a04edd4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IEC-Innoview GmbH
• Version Model Number: 30-0494-00
• Catalog Number: 30-0494-00
• 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

• Outer Diameter: 5 Millimeter
• Length: 300 Millimeter
• Angle: 0 degree
• Outer Diameter: 5 Millimeter
• Length: 300 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B192300494000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982276

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[B192300494000]

Moist Heat or Steam Sterilization

[B192300494000]

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]

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• 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