EXAMIX™ 137032

GUDID 10386040005227

EXAMIX™ NDS Regular (blue) 32-Packs (32 x 48mL cartridges)

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 10386040005227
• NIH Device Record Key: b7f02088-1302-42ef-a78f-731c5a2f0038
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXAMIX™
• Version Model Number: 137032
• Catalog Number: 137032
• 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 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040005227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955932

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 [EXAMIX™]

• 10386040005579: EXAMIX™ NDS Monophase (purple) 32-Packs (32 x 48mL cartridges)
• 10386040005449: EXAMIX™ NDS Heavy (yellow) 80-Packs (80 x 48mL cartridges)
• 10386040005432: EXAMIX™ NDS Monophase (purple) 80-Packs (80 x 48mL cartridges)
• 10386040005425: EXAMIX™ NDS Regular (blue) 80-Packs (80 x 48mL cartridges)
• 10386040005418: EXAMIX™ NDS Injection (copper) 80-Packs (80 x 48mL cartridges)
• 10386040005395: EXAMIX™ NDS Heavy (yellow) 32-Packs (32 x 48mL cartridges)
• 20386040005378: EXAMIX™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040005340: EXAMIX™ NDS Injection (copper) 32-Packs (32 x 48mL cartridges)
• 20386040005316: EXAMIX™ NDS Injection (copper) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 10386040005296: EXAMIX™ NDS Monophase (purple) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005289: EXAMIX™ NDS Regular (blue) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005272: EXAMIX™ NDS Injection (copper) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005265: EXAMIX™ NDS Heavy (yellow) Value Packs (8 x 48mL cartridges, 24 x mixing tips)
• 10386040005227: EXAMIX™ NDS Regular (blue) 32-Packs (32 x 48mL cartridges)
• 20386040005200: EXAMIX™ NDS Regular (blue) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
• 20386040000663: EXAMIX™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)