Plasdent UltraProof Earloop Mask MK3-2

GUDID D832MK325

DuralProof(TM) Earloop Face Mask - Blue (40pcs/box)

PLASDENT CORPORATION

Antimicrobial surgical/medical respirator

• Primary Device ID: D832MK325
• NIH Device Record Key: 51c87726-86e2-4e5e-a90b-a346fccd65be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plasdent UltraProof Earloop Mask
• Version Model Number: MK2
• Catalog Number: MK3-2
• 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	D832MK32 [Primary]
HIBCC	D832MK321 [Package]; Contains: D832MK32; Package: box [40 Units]; In Commercial Distribution
HIBCC	D832MK322 [Package]; Contains: D832MK321; Package: Case [20 Units]; In Commercial Distribution
HIBCC	D832MK325 [Package]; Contains: D832MK32; Package: case [800 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 UltraProof Earloop Mask]

• D832MKS325: ULTRAPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
• D832MK325: DuralProof(TM) Earloop Face Mask - Blue (40pcs/box)