Trophon Chemical Indicator

GUDID 09350855000047

Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)

NANOSONICS LIMITED

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator

• Primary Device ID: 09350855000047
• NIH Device Record Key: 309f56f0-09ce-491e-8383-7443cc3a550e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trophon Chemical Indicator
• Version Model Number: N00091
• Company DUNS: 741021943
• Company Name: NANOSONICS LIMITED
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350855000047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103126

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2016-09-21

On-Brand Devices [Trophon Chemical Indicator]

• 09350855000177: Chemical Indicator
• 09350855000054: Chemical Indicator US SP-P18 (NNA VARIANT)
• 09350855000047: Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT)
• 09350855000542: Chemical Indicator