BITE-RITE BIT-9005

GUDID 20818524020534

M&S DENTAL BITE-RITE BITE MINT CHOC CHIP SUPER FAST SET - 50 mL CART

CROWN DELTA CORPORATION

Silicone dental impression material

• Primary Device ID: 20818524020534
• NIH Device Record Key: 561c4528-20ad-4b1d-a66d-5b3355332b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BITE-RITE
• Version Model Number: BIT-9005
• Catalog Number: BIT-9005
• 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: false
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818524020530 [Primary]
GS1	10818524020537 [Package]; Contains: 00818524020530; Package: KIT [2 Units]; In Commercial Distribution
GS1	20818524020534 [Package]; Contains: 10818524020537; Package: CASE [10 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-05

On-Brand Devices [BITE-RITE]

• 20818524020657: M&S DENTAL BITE-RITE BITE MINT CHOC CHIP FAST SET - 50 mL CART
• 10818524020612: M&S DENTAL BITE-RITE BITE SUPER FAST SET - 50 mL CART
• 20818524020534: M&S DENTAL BITE-RITE BITE MINT CHOC CHIP SUPER FAST SET - 50 mL CART
• 20818524020442: M&S DENTAL BITE-RITE CLEAR FAST SET - 50 mL CART
• 20818524020282: M&S DENTAL BITE-RITE BITE FAST SET - 50 mL CART
• 20818524020206: M&S DENTAL BITE-RITE BITE SUPER FAST SET - 50 mL CART
• 20818524020176: M&S DENTAL BITE-RITE BITE REGULAR SET 50 mL CART