Perflex Biosens 411006

GUDID 07290110501426

Biosens Thermolplastic pellets for dentures by injection molding Shade Transparent Clear 200gr. net in jar packed in box

PERFLEX LTD

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 07290110501426
• NIH Device Record Key: 3cd20909-cfba-4bd5-9053-97600296208d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perflex Biosens
• Version Model Number: Transparent Clear 200gr. jar
• Catalog Number: 411006
• Company DUNS: 532176000
• Company Name: PERFLEX LTD
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +97298825473
• Email: vidal@perflexltd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290110501426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150454

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2017-03-14

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