MD-ChelCream 2.5

GUDID 08806387893127

MD-ChelCream is used to removal the inorganic and organic material as the root canal cleanser.

Meta Biomed Co., Ltd.

Root canal cleaning solution

• Primary Device ID: 08806387893127
• NIH Device Record Key: d08a8cc6-2f0a-4900-813d-17c8ae1da66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD-ChelCream 2.5
• Version Model Number: 9312
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387893127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232299

FDA Product Code

• EKQ: Preparer, Root Canal Endodontic
• KIF: Resin, Root Canal Filling

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: 2022-10-03
• Device Publish Date: 2022-09-24

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