DH Nyclave Indicator Labels

GUDID 10302731163120

Dry Heat sterilization indicators

YOUNG DENTAL MANUFACTURING I, LLC

Chemical/physical sterilization process indicator

• Primary Device ID: 10302731163120
• NIH Device Record Key: 2ac5fe12-20de-45f9-a297-6760086add47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DH Nyclave Indicator Labels
• Version Model Number: 116312
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• 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: false
• 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	10302731163120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890761

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: 2016-09-23

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