EO Chex 1" Indicator Tape - 36 rolls/case 26811600

GUDID 10818087011089

EO Chex 1" Indicator Tape - 36 rolls/case

PROPPER MANUFACTURING COMPANY, INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 10818087011089
• NIH Device Record Key: 3457a1c9-b83c-4497-ad61-4f9eff761069
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EO Chex 1" Indicator Tape - 36 rolls/case
• Version Model Number: 26811600
• Catalog Number: 26811600
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 36
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818087011089 [Unit of Use]
GS1	70818087011081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240910

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-05
• Device Publish Date: 2024-07-26

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