BARRIER BB-0528X-1

GUDID H816BB0528X2

5 x 28 Instrument / equipment drape, single-use, non-sterile x-ray sox

CERTOL INTERNATIONAL, LLC

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: H816BB0528X2
• NIH Device Record Key: a12db8a1-d5e4-4832-a7d1-7bedd5473fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BARRIER
• Version Model Number: BB-0528X
• Catalog Number: BB-0528X-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, 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	H816BB0528X0 [Unit of Use]
HIBCC	H816BB0528X1 [Primary]
HIBCC	H816BB0528X2 [Package]; Contains: H816BB0528X1; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [BARRIER]

• H816DC0115S2: Disposable dental bib connnector with tape
• H816BB2930C2: 29 x 30 Instrument / equipment drape chair sox
• H816BB0528X2: 5 x 28 Instrument / equipment drape, single-use, non-sterile x-ray sox
• H816BB0312H2: 3 x 12 instrument / equipment drape, chair sox