Endochoice Drive Wire FSA-7501

GUDID 00817658020195

When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual. These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

ZUTRON MEDICAL, L.L.C.

Colonoscope stiffener Colonoscope stiffener

• Primary Device ID: 00817658020195
• NIH Device Record Key: 1bce7ed0-6161-4bb9-9748-425729541b10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endochoice Drive Wire
• Version Model Number: FSA-7501
• Catalog Number: FSA-7501
• Company DUNS: 962532441
• Company Name: ZUTRON MEDICAL, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817658020195 [Primary]

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

[00817658020195]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-01

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