ProBarrier BB-0528X-1

GUDID H816MBB0528X2

Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox

MicroCare, LLC

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• Primary Device ID: H816MBB0528X2
• NIH Device Record Key: 5d95f848-cdb6-4bab-b789-b440843b2438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBarrier
• Version Model Number: BB-0528X
• Catalog Number: BB-0528X-1
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• Device Count: 250
• 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	H816BB0528X1 [Previous]
HIBCC	H816MBB0528X0 [Unit of Use]
HIBCC	H816MBB0528X1 [Primary]
HIBCC	H816MBB0528X2 [Package]; Contains: H816MBB0528X1; Package: Case Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922175

FDA Product Code

• KLC: Chair, Dental, With Operative Unit

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: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [ProBarrier]

• H816MDC0115S2: Disposable Bib Chain
• H816MBB2930C2: Environmental surface barrier, 29" x 30" Instrument/equipment drape chair sox
• H816MBB0528X2: Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox
• H816MBB0312H2: Environmental Surface Barrier, 3 x 12 instrument/equipment drape, chair sox