Disposable Dilators

GUDID 00878953005379

Disposable Dilators, Set of 2 Dilators (9-12 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator

AMERICAN MEDICAL SYSTEMS, INC.

Corpus cavernosum dilator, single-use

• Primary Device ID: 00878953005379
• NIH Device Record Key: ae0a73b7-3b70-4e16-8ecb-c228ff09830f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Dilators
• Version Model Number: 720131-01
• Company DUNS: 125111448
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005379 [Primary]

FDA Product Code

• KOA: Surgical Instruments, G-U, Manual (And Accessories)

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: 2014-09-25

On-Brand Devices [Disposable Dilators]

• 00878953005379: Disposable Dilators, Set of 2 Dilators (9-12 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator
• 00878953005355: Disposable Dilators, Set of 4 Dilators (9-16 mm) 1) 9-10 mm Dilator 1) 11-12 mm Dilator 1) 1