Perflex Biosens 411004

GUDID 07290110501402

Biosens Thermoplastic pellets for dentures by injection molding Shade Standard Pink 200gr. net filled in jar and packed in box

PERFLEX LTD

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 07290110501402
• NIH Device Record Key: 21193482-064c-4f67-b3bf-108d909d53a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perflex Biosens
• Version Model Number: Standard Pink 200gr. jar
• Catalog Number: 411004
• 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: false
• 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	07290110501402 [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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