MEDIVISION MV5545

GUDID 00851328007130

The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic procedures, such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The Laparoscope may be attached to hand-held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The Laparoscope is designed to pass through standard laparoscopic and thoracoscopic cannulas to gain access to the subject surgical site.

MEDIVISION, INC.

Rigid optical laparoscope

• Primary Device ID: 00851328007130
• NIH Device Record Key: 95bb22db-6813-4011-9681-d1b2c29a299b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDIVISION
• Version Model Number: MV5545
• Catalog Number: MV5545
• Company DUNS: 942192550
• Company Name: MEDIVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851328007130 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00851328007130]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-14

On-Brand Devices [MEDIVISION]

• 00851328007222: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007215: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007208: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007192: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007185: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007178: CYSTOSCOPE MediVision Cystoscope is for examine of the lower urinary tract, and using additional
• 00851328007161: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007154: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007147: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007130: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007123: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007116: The MediVision Laparoscope is intended to be used by qualified physicians to provide access, ill
• 00851328007109: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007093: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007086: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007079: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007062: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007055: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007048: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007031: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007024: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,
• 00851328007017: ARTHROSCOPE Intended use of MediVision Arthroscope is for orthopedic use in the knee, shoulder,