BI-OK Steam Vials (20/pack)

GUDID 30818087012332

BI-OK Steam Vials (20/pack)

PROPPER MANUFACTURING COMPANY, INC.

Biological sterilization indicator

• Primary Device ID: 30818087012332
• NIH Device Record Key: c60a8d84-ad6c-47b1-b690-e7947b3e6f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BI-OK Steam Vials (20/pack)
• Version Model Number: 26920000
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 20
• 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	10818087012338 [Unit of Use]
GS1	30818087012332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891784

FDA Product Code

• FRC: Indicator, Biological 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: 2019-03-19
• Device Publish Date: 2019-03-11

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