STABILINER CD002

GUDID 10866738000227

STABILINER STANDARD SET INTRO KIT 1 CART AND 10 KITS BROWN MIXERS 20 PER CASE (HS PART # 9973204)

CROWN DELTA CORPORATION

Dental composite resin

• Primary Device ID: 10866738000227
• NIH Device Record Key: d31e07c2-08f8-4c75-927b-8153a7bd44d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STABILINER
• Version Model Number: CD002
• Catalog Number: CD002
• Company DUNS: 030479000
• Company Name: CROWN DELTA CORPORATION
• 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: true
• 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: (914) 245-8910
• Email: SALES01@CROWNDELTA.COM

Device Dimensions

• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 72 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866738000220 [Primary]
GS1	10866738000227 [Package]; Contains: 00866738000220; Package: KIT [1 Units]; In Commercial Distribution

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-03

On-Brand Devices [STABILINER]

• 00866738000237: STABILINER STANDARD SET REFILL KIT 2 CART 10 KITS PER CASE
• 10866738000227: STABILINER STANDARD SET INTRO KIT 1 CART AND 10 KITS BROWN MIXERS 20 PER CASE (HS PART # 997320
• 10866738000210: STABILINER QUICK SET REFILL KIT 2 CART 10 KITS PER CASE
• 00866738000206: STABILINER QUICK SET INTRO KIT 1 CART AND 20 BROWN MIXERS 10 KITS PER CASE