Versacryl 1014026

GUDID H66810140261

Acrylic Pink 25 lb Pwd bucket

Keystone Industries

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• Primary Device ID: H66810140261
• NIH Device Record Key: a0bc4723-05b9-4609-9232-940667584a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versacryl
• Version Model Number: 1014026
• Catalog Number: 1014026
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Dimensions

• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound
• Weight: 25 Pound

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66810140261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012882

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [Versacryl]

• H66810140391: SC Reline Intro Kit, 1-50g pink Pwd, 1-60 ml premix Liq
• H66810140341: HC Reline Kit, 2-50 g Pink Pwd. 2-60 ml pre-mix Liq.
• H66810140331: SC Reline Kit, 2-50 g Pink Pwd. 2-60 ml pre-mix Liq.
• H66810140321: HC Lab Kit, 2-50g Pwd, 1-60 ml Liq. hardener, 1-60 ml Liq. softener
• H66810140311: SC Lab Kit, 2-50g Pwd, 1-60 ml Liq. hardener, 1-60 ml Liq. softener
• H66810140251: 2 oz Sealer
• H66810140241: 1/2 oz Sealer
• H66810140231: Acrylic Pink 1 lb Pwd
• H66810140221: Acrylic Clear 1 lb Pwd
• H66810140211: Acrylic Pink 2 oz Pwd
• H66810140201: Acrylic Clear 2 oz Pwd
• H66810140191: Acrylic HC Pre-Mixed Liquid 1 Qt
• H66810140181: Acrylic SC Pre-Mixed Liquid 1 Qt
• H66810140171: Acrylic HC Hardener Liquid 1 Qt
• H66810140161: Acrylic SC Hardener Liquid 1 Qt
• H66810140151: Reline Softening Liquid 1 Qt
• H66810140141: Acrylic HC Pre-Mixed Liquid 60 ml
• H66810140131: Acrylic SC Pre-Mixed Liquid 60 ml
• H66810140121: Acrylic HC Hardener Liquid, 60 ml
• H66810140111: Acrylic SC Hardener Liquid 60 ml
• H66810140101: Acrylic Softening Liquid, 60 ml
• H66810140261: Acrylic Pink 25 lb Pwd bucket