Proflex 9641000

GUDID H66896410001

NFC Medium Super Econo Kit

Keystone Industries

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• Primary Device ID: H66896410001
• NIH Device Record Key: d1b6ad1c-001d-492d-a5a7-1f1a1cd19bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proflex
• Version Model Number: 9641000
• Catalog Number: 9641000
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated
• Special Storage Condition, Specify: Between 0 and 0 *For best results keep refrigerated

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66896410001 [Primary]

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: 5
• Public Version Date: 2023-06-27
• Device Publish Date: 2016-09-15

On-Brand Devices [Proflex]

• H66891465751: Flexible NFC Liquid 120g
• H66891465701: Flexible NFC Liquid 240g
• H66891465601: NFC Medium Super Econo Kit
• H66891465511: NFC Medium Resin
• H66891465401: NFC Light Super Econo Kit
• H66891465351: NFC Light Resin
• H66891465101: NFC Firm Clear Resin
• H66891464901: NFC Dark Super Econo Kit
• H66891464851: NFC Dark Resin
• H66891464701: NFC Clear Super Econo Kit
• H66891464651: NFC Clear Resin
• H66891464301: NFC Medium Resin
• H66891463901: NFC Light Resin
• H66891462001: NFC Clear Resin
• H66896403600: Pro-flex Clear Wire Clasp Material
• H66896410001: NFC Medium Super Econo Kit
• H66896408901: NFC Clear Super Econo Kit