COE-FLEX® 131004

GUDID 20386040004821

COE-FLEX® Standard Package Heavy Body (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)

Gc America Inc.

Polyether dental impression material

• Primary Device ID: 20386040004821
• NIH Device Record Key: 285924de-acd6-47e0-bc60-8f8cf0c00e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COE-FLEX®
• Version Model Number: 131004
• Catalog Number: 131004
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040004824 [Primary]
GS1	20386040004821 [Package]; Contains: 10386040004824; Package: Carton [12 Units]; In Commercial Distribution

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [COE-FLEX®]

• 10386040004954: COE-FLEX® s Regular Body, Fast Set (catalyst only) (1 x 45mL catalyst)
• 10386040004947: COE-FLEX® s Heavy Body (catalyst only) (1 x 45mL catalyst)
• 10386040004930: COE-FLEX® s Injection Type (catalyst only) (1 x 45mL catalyst)
• 10386040004923: COE-FLEX® s Regular Body (catalyst only) (1 x 45mL catalyst)
• 10386040004916: COE-FLEX® s Regular Body, Fast Set (base only) (1 x 90mL base)
• 10386040004909: COE-FLEX® s Heavy Body (base only) (1 x 90mL base)
• 10386040004893: COE-FLEX® s Injection Type (base only)(1 x 90mL base)
• 10386040004886: COE-FLEX® s Regular Body (base only) (1 x 90mL base)
• 20386040004876: COE-FLEX® s Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst)
• 20386040004869: COE-FLEX® s Heavy Body (1 x 90mL base, 1 x 45mL catalyst)
• 20386040004852: COE-FLEX® s Injection Type (1 x 90mL base, 1 x 45mL catalyst)
• 20386040004845: COE-FLEX® s Regular Body (1 x 90mL base, 1 x 45mL catalyst)
• 20386040004838: COE-FLEX® Standard Package Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL a
• 20386040004821: COE-FLEX® Standard Package Heavy Body (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
• 20386040004814: COE-FLEX® Standard Package Injection Type (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
• 20386040004807: COE-FLEX® Standard Package Regular Body (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
• D6581313051: COE-FLEX® s Regular Body, Fast Set (catalyst only) (1 x 45mL catalyst)
• D6581313041: COE-FLEX® s Heavy Body (catalyst only) (1 x 45mL catalyst)
• D6581313031: COE-FLEX® s Injection Type (catalyst only) (1 x 45mL catalyst)
• D6581313021: COE-FLEX® s Regular Body (catalyst only) (1 x 45mL catalyst)
• D6581312051: COE-FLEX® s Regular Body, Fast Set (base only) (1 x 90mL base)
• D6581312041: COE-FLEX® s Heavy Body (base only) (1 x 90mL base)
• D6581312031: COE-FLEX® s Injection Type (base only)(1 x 90mL base)
• D6581312021: COE-FLEX® s Regular Body (base only) (1 x 90mL base)
• D6581311052: COE-FLEX® s Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst)
• D6581311042: COE-FLEX® s Heavy Body (1 x 90mL base, 1 x 45mL catalyst)
• D6581311032: COE-FLEX® s Injection Type (1 x 90mL base, 1 x 45mL catalyst)
• D6581311022: COE-FLEX® s Regular Body (1 x 90mL base, 1 x 45mL catalyst)
• D6581310052: COE-FLEX® Standard Package Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL a
• D6581310042: COE-FLEX® Standard Package Heavy Body (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
• D6581310032: COE-FLEX® Standard Package Injection Type (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
• D6581310022: COE-FLEX® Standard Package Regular Body (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)