Burkhart Level 3 Earloop Mask w/Chin Fit, White (50)

GUDID 00815878020650

BURKHART DENTAL SUPPLY CO., THE

Surgical/medical face mask, single-use

• Primary Device ID: 00815878020650
• NIH Device Record Key: 8b904457-6a9d-4602-befb-401f15a9d10e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart Level 3 Earloop Mask w/Chin Fit, White (50)
• Version Model Number: 72720816
• Company DUNS: 027532357
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Device Count: 50
• 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: 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	00815878020582 [Unit of Use]
GS1	00815878020599 [Primary]
GS1	00815878020605 [Package]; Contains: 00815878020599; Package: Case [10 Units]; In Commercial Distribution
GS1	00815878020650 [Package]; Contains: 00815878020599; Package: Sample [3 Units]; In Commercial Distribution
GS1	10815878020596 [Package]; Contains: 00815878020599; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-06-30

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