Plasdent DuralProof Earloop Mask MK2-6

GUDID D832MK265

DuralProof(TM) Earloop Face Mask - Pink (50pcs/box)

PLASDENT CORPORATION

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• Primary Device ID: D832MK265
• NIH Device Record Key: 229b37e2-13cc-49f6-95e3-9c4145ad5b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent DuralProof Earloop Mask
• Version Model Number: MK2
• Catalog Number: MK2-6
• Company DUNS: 190377184
• Company Name: PLASDENT CORPORATION
• 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: 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
HIBCC	D832MK26 [Primary]
HIBCC	D832MK261 [Package]; Contains: D832MK26; Package: box [50 Units]; In Commercial Distribution
HIBCC	D832MK265 [Package]; Contains: D832MK26; Package: case [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133070

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-09-21

On-Brand Devices [Plasdent DuralProof Earloop Mask]

• D832MK265: DuralProof(TM) Earloop Face Mask - Pink (50pcs/box)
• D832MK225: DuralProof(TM) Earloop Face Mask - Blue (50pcs/box)