PowerMix™ Automatic Impression Material Dispenser 031121

GUDID 07540172012454

Two-component dental material applicator, electric

CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Two-component dental material applicator, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric Dental material cartridge-plunging applicator, two-component, electric

• Primary Device ID: 07540172012454
• NIH Device Record Key: cf94ce7a-24a6-4a34-bc65-7476712bc0b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerMix™ Automatic Impression Material Dispenser
• Version Model Number: 031121
• Catalog Number: 031121
• Company DUNS: 626406016
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com
• Phone: +1(800)265-3444
• Email: info@clinicianschoice.com

Device Dimensions

• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram
• Device Size Text, specify: 0
• Weight: 765 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight. Maximum relative humidity 80%

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540172012454 [Primary]

FDA Product Code

• EFD: AMALGAMATOR, DENTAL, AC-POWERED

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: 2019-03-12
• Device Publish Date: 2018-09-10