Plasdent FluidProof Earloop Mask MKS1-2

GUDID D832MKS125

FLUIDPROOF (TM) Earloop Mask with Shield- Blue (25pcs/box)

PLASDENT CORPORATION

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• Primary Device ID: D832MKS125
• NIH Device Record Key: 6a063300-b226-423c-b3d1-d1cdfca0d512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent FluidProof Earloop Mask
• Version Model Number: MKS1
• Catalog Number: MKS1-2
• 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	D832MKS12 [Primary]
HIBCC	D832MKS121 [Package]; Contains: D832MKS12; Package: BOX [25 Units]; In Commercial Distribution
HIBCC	D832MKS122 [Package]; Contains: D832MKS121; Package: Case [10 Units]; In Commercial Distribution
HIBCC	D832MKS125 [Package]; Contains: D832MKS12; Package: CASE [250 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: 2018-09-27

On-Brand Devices [Plasdent FluidProof Earloop Mask ]

• D832MKS165: FLUIDPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
• D832MKS125: FLUIDPROOF (TM) Earloop Mask with Shield- Blue (25pcs/box)