Sizer

GUDID 00878953005386

1 Sizer 9.5 mm Diameter (00878953000497), 1 Sizer 12 mm Diameter (00878953000503)

AMERICAN MEDICAL SYSTEMS, INC.

Medical ruler, reusable

• Primary Device ID: 00878953005386
• NIH Device Record Key: 388a37a0-81da-439a-86f7-91043717a38c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sizer
• Version Model Number: 720153-01
• 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: 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 Dimensions

• Outer Diameter: 9.5 Millimeter
• Outer Diameter: 9.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005386 [Primary]

FDA Product Code

• JCW: Prosthesis, Penis, Inflatable

Sterilization

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

[00878953005386]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-03-31

On-Brand Devices [Sizer]

• 00878953005386: 1 Sizer 9.5 mm Diameter (00878953000497), 1 Sizer 12 mm Diameter (00878953000503)
• 00878953000503: Cylinder Sizing Tool
• 00878953000497: Cylinder Sizing Tool