Durette® IV, regular

GUDID 20697660002549

External laser shields, all-stainless-steel patient's goggles, regular, with 4 stainless-steel attachments, 2 elastic headbands and a case This stainless steel (surface treated) eye wear covers all wavelengths. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT.

Oculo-Plastik Inc

Epiocular radiation shield, reusable

• Primary Device ID: 20697660002549
• NIH Device Record Key: 8f508a67-f735-44f7-9786-5ea199dd3c84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durette® IV, regular
• Version Model Number: 21-555
• Company DUNS: 257382580
• Company Name: Oculo-Plastik Inc
• 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: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 514-381-3292
• Email: sales@oculoplastik.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20697660002549 [Primary]

FDA Product Code

• IWS: Shield, Eye, Radiological

Sterilization

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

[20697660002549]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

Devices Manufactured by Oculo-Plastik Inc

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