Perflex T-CRYSTAL 112506

GUDID 07290110500160

Box of 6 Medium cartridges 25mm Diameter and 73mm long, 18gr. net of Thermoplastic T-CRYSTAL Standard Pink filled inside of each cartridge sealed in a

PERFLEX LTD

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 07290110500160
• NIH Device Record Key: ec980891-bf74-4391-9777-ea2be8a237bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perflex T-CRYSTAL
• Version Model Number: Cartridge STD Pink Medium Diameter 25mm
• Catalog Number: 112506
• 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	07290110500160 [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

Devices Manufactured by PERFLEX LTD

• 07290110501372 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink 1kg net filled in jar and packed in box
• 07290110501389 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink 200gr. net filled in jar and packed in box
• 07290110501433 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 1kg net filled in jar and packed in box
• 07290110501440 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Purple Pink 200gr. net filled in jar and packed in box
• 07290110501457 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Opaque Pink 1kg net filled in jar and packed in box
• 07290110501464 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Opaque Pink 200gr. net filled in jar and packed in box
• 07290110501471 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink Clear 1kg net filled in jar and packed in box
• 07290110501488 - Perflex Biosens: 2022-11-16 Biosens Thermoplastic pellets for dentures by injection molding Shade Light Pink Clear 200gr. net filled in jar and packed in bo