GC CERAMIC PRIMER II 008551

GUDID 14548161282611

GC CERAMIC PRIMER II

Gc America Inc.

Dental etching solution

• Primary Device ID: 14548161282611
• NIH Device Record Key: 4d66a890-c5b8-486d-841c-1bc32f364417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC CERAMIC PRIMER II
• Version Model Number: 008551
• Catalog Number: 008551
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• 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(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 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161282611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001823

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2022-08-15
• Device Publish Date: 2022-08-05

On-Brand Devices [GC CERAMIC PRIMER II]

• 04548161297304: GC CERAMIC PRIMER II Unit Dose, 10 pieces
• 14548161282611: GC CERAMIC PRIMER II