Propper 26610300

GUDID 70818087011777

INDICATOR STEAM OAD BOWIE DICK

PROPPER MANUFACTURING COMPANY, INC.

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

• Primary Device ID: 70818087011777
• NIH Device Record Key: 842cc2f1-369e-4805-9ec9-59812e66cf09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propper
• Version Model Number: Once-A-Day Bowie Dick Test
• Catalog Number: 26610300
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 30
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818087011775 [Unit of Use]
GS1	70818087011777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961156

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

Devices Manufactured by PROPPER MANUFACTURING COMPANY, INC.

• 10818087010815 - Seraket Tourniquets: 2023-06-26 Seraket Tourniquet - 1 EA
• 10818087010952 - Gas-Chex EO Gas 3/4" Indicator Tape: 2023-06-26 Gas-Chex EO Gas 3/4" Indicator Tape - 1 RL
• 10818087010914 - Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 1/2" x 14 YD - 24/pack
• 10818087010938 - Verline Steam Autoclave Indicator Tape 3/4" x 14 YD - 16/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 3/4" x 14 YD - 16/pack
• 10818087010945 - Verline Steam Autoclave Indicator Tape 1" x 14 YD - 12/pack: 2023-06-26 Verline Steam Autoclave Indicator Tape 1" x 14 YD - 12/pack
• 30818087010994 - Vapor Line Reusable Process Challenge Device: 2023-06-26 Vapor Line Reusable Process Challenge Device
• 10818087011003 - BI-OK Ethylene Oxide Gas Vials: 2023-06-26 BI-OK Ethylene Oxide Gas Vials - Box of 100
• 10818087010822 - Seraket Tourniquets: 2023-06-26 Seraket Tourniquet - Case of 120