Furlow Insertion Tool

GUDID 00878953000176

Cylinder Insertion Tool

AMERICAN MEDICAL SYSTEMS, INC.

Gastro-urological director

• Primary Device ID: 00878953000176
• NIH Device Record Key: 697fef5d-fc5f-48bb-a398-3a33cd2b003f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Furlow Insertion Tool
• Version Model Number: 35400010
• Company DUNS: 125111448
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953000176 [Primary]
GS1	00878953000510 [Direct Marking]

FDA Product Code

• JCW: Prosthesis, Penis, Inflatable

Sterilization

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

[00878953000176]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-25

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