V-Cide VC338-1

GUDID H816VC3381

Formaldehyde Device Sterilant

CERTOL INTERNATIONAL, LLC

Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant Formaldehyde device sterilant

• Primary Device ID: H816VC3381
• NIH Device Record Key: f4e1b0be-60d3-4e51-a229-447de4c7f246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Cide
• Version Model Number: VC338
• Catalog Number: VC338-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• 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: 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	H816VC3380 [Primary]
HIBCC	H816VC3381 [Package]; Contains: H816VC3380; Package: Case Box [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970726

FDA Product Code

• MED: Sterilant, Medical Devices

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

Devices Manufactured by CERTOL INTERNATIONAL, LLC

• H816QEZ22 - QEZ: 2023-06-12
• H816PFL0082 - Shield: 2020-05-06 High-Efficiency Face Mask with Headband
• H816PFLEL82 - Shield: 2020-05-06 High-Efficiency Face Mask w/ Earloop
• H816PM10161 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 10" X 16"
• H816PM13181 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM13191 - ProView plus: 2019-11-08 Self-Sealing Sterilization Pouch/Packaging 13" X 18"
• H816PM24402 - ProView plus: 2019-11-08 Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
• H816PM27902 - ProView plus: 2019-11-08 Self Sealing Sterilization Pouch/Packaging 2 3/4" X 9"