AdVance

GUDID 00878953005881

Needle Passers

AMERICAN MEDICAL SYSTEMS, INC.

Stress urinary incontinence surgical mesh, male

• Primary Device ID: 00878953005881
• NIH Device Record Key: 44652516-60cb-4d40-90dc-56d65322d889
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdVance
• Version Model Number: 84414379
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00878953005881 [Primary]

FDA Product Code

• OTM: Mesh, Surgical, For Stress Urinary Incontinence, Male

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-07-22

On-Brand Devices [AdVance ]

• 00878953005898: Male Sling
• 00878953005881: Needle Passers
• 00878953005300: Male Sling System 1 Male Sling, 2 Needle Passers, 1 Percutaneous Needle, 1 Retractor Ring, 8 Blu