ProBarrier DC-0115S-1

GUDID H816MDC0115S2

Disposable Bib Chain

MicroCare, LLC

Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib Dental bib

• Primary Device ID: H816MDC0115S2
• NIH Device Record Key: 1c6fbf28-4cb0-45e5-ad47-6c3d09d50835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProBarrier
• Version Model Number: DC-0115S
• Catalog Number: DC-0115S-1
• Company DUNS: 118518186
• Company Name: MicroCare, LLC
• Device Count: 300
• 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	H816DC0115S1 [Previous]
HIBCC	H816MDC0115S0 [Unit of Use]
HIBCC	H816MDC0115S1 [Primary]
HIBCC	H816MDC0115S2 [Package]; Contains: H816MDC0115S1; 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