PeriOptix® 200POPTIX

GUDID D813200POPTIX0

PERIOPTIX KIT ASSEMBLY

DEN-MAT HOLDINGS, LLC

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• Primary Device ID: D813200POPTIX0
• NIH Device Record Key: 75b6008b-4c91-459b-a1e0-702d21e6a3e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PeriOptix®
• Version Model Number: 200POPTIX
• Catalog Number: 200POPTIX
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true

Customer Support Contacts

• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813200POPTIX0 [Primary]

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [PeriOptix®]

• D813LPMM0: PUPILIOMETER
• D813AREPKITNA0: PERIOPTIX REP KIT US/CN
• D813ALED60: LUMIPRO HEADLIGHT SYSTEM
• D813ALED5R0: FIREFLY UNIT RED
• D813ALED5B0: FIREFLY UNIT BLUE
• D813ALED50: FIREFLY UNIT
• D813200POPTIX0: PERIOPTIX KIT ASSEMBLY