AMS 700 Accessory Kit

GUDID 00878953001135

Inflatable Penile Prosthesis Accessory Kit

AMERICAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00878953001135
• NIH Device Record Key: 00fe97d5-90f8-4092-9e08-d8e0efbd2810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 Accessory Kit
• Version Model Number: 72401850
• 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: true
• 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	00878953001135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N970012

FDA Product Code

• JCW: Prosthesis, Penis, Inflatable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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