ProView plus PM3554-1

GUDID H816PM35542

Self-Sealing Sterilization Pouch/Packaging 3.5" X 5.25"

CERTOL INTERNATIONAL, LLC

Sterilization packaging, single-use

• Primary Device ID: H816PM35542
• NIH Device Record Key: 9eaad2ad-b331-4008-96c0-628519d10fb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProView plus
• Version Model Number: PM3554
• Catalog Number: PM3554-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• Device Count: 200
• 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: true
• 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	H816PM35540 [Unit of Use]
HIBCC	H816PM35541 [Primary]
HIBCC	H816PM35542 [Package]; Contains: H816PM35541; Package: Case Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-09-23

On-Brand Devices [ProView plus]

• H816PM75132: Self-Sealing Sterilization Pouch/Packaging 7.5" x 13"
• H816PM54102: Self-Sealing Sterilization Pouch/Packaging 5.25" x 10"
• H816PM35902: Self-Sealing Sterilization Pouch/Packaging 3.5" x 9"
• H816PM35542: Self-Sealing Sterilization Pouch/Packaging 3.5" X 5.25"
• H816PM27902: Self Sealing Sterilization Pouch/Packaging 2 3/4" X 9"
• H816PM24402: Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
• H816PM13191: Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM13181: Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM10161: Self-Sealing Sterilization Pouch/Packaging 10" X 16"