RevoWave™ RWSA-3555I

GUDID 14545428038325

0.035 Standard

PIOLAX MEDICAL DEVICES, INC.

Gastro-urological guidewire, single-use

• Primary Device ID: 14545428038325
• NIH Device Record Key: 6102ffa4-45b7-4e74-bb27-3a0abcd283b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RevoWave™
• Version Model Number: RWSA-3555I
• Catalog Number: RWSA-3555I
• Company DUNS: 693961984
• Company Name: PIOLAX MEDICAL DEVICES, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

• Length: 550 Centimeter
• Length: 550 Centimeter
• Length: 550 Centimeter
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter
• Device Size Text, specify: 0
• Length: 550 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to high temperature, high humidity, direct sunlight, ultraviolet light (from germicidal lamp, etc.) and water during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	04545428038328 [Primary]
GS1	14545428038325 [Package]; Contains: 04545428038328; Package: Carton [1 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic Guidewire, Gastroenterology-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-01
• Device Publish Date: 2019-03-22

On-Brand Devices [RevoWave™]

• 14545428038714: 0.025 Hard
• 14545428038707: 0.025 Hard
• 14545428038691: 0.035 Hard
• 14545428038684: 0.035 Hard
• 14545428038646: 0.025 UltraHard
• 14545428038639: 0.035 Standard
• 14545428038370: 0.025 Hard
• 14545428038363: 0.035 Hard
• 14545428038356: 0.025 Hard
• 14545428038349: 0.025 Hard
• 14545428038332: 0.025 UltraHard
• 14545428038325: 0.035 Standard
• 14545428038318: 0.035 Standard
• 14545428038301: 0.035 Standard
• 14545428038295: 0.035 UltraHard
• 14545428038288: 0.035 Hard
• 04545428038274: 0.035 Hard
• 14545428038264: 0.035 Standard
• 14545428038257: 0.035 Standard