PERFECTO DW57

GUDID 10818524020018

PERFECTO MONOPHASE SHM REGULAR/SET 2 PACK CARTRIDGE KIT

CROWN DELTA CORPORATION

Silicone dental impression material Silicone dental impression material

• Primary Device ID: 10818524020018
• NIH Device Record Key: 9dc77707-d0e7-48e1-a658-1895d2b20273
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFECTO
• Version Model Number: DW57
• Catalog Number: DW57
• 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: 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

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	00818524020011 [Primary]
GS1	10818524020018 [Package]; Contains: 00818524020011; Package: KIT [2 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: 2018-02-16

On-Brand Devices [PERFECTO]

• 10818524020353: PERFECTO MONOPHASE SHM FAST/SET 2 PACK CARTRIDGE KIT
• 10818524020315: PERFECTO CAD-CAM FAST SET CARTRIDGE
• 00818524020295: PERFECTO LIGHT BODY SHM YELLOW TUBE KIT
• 10818524020278: PERFECTO HEAVY BODY SHM REGULAR SET
• 10818524020254: PERFECTO LIGHT BODY SHM YELLOW FAST SET - 50 mL CARTRIDGE
• 10818524020247: PERFECTO LIGHT BODY SHM YELLOW REGULAR SET - 50 mL CARTRIDGE
• 00818524020196: PERFECTO VINYL PUTTY FAST SET (A & B) KIT
• 00818524020042: PERFECTO VINYL PUTTY REGULAR SET (A & B) KIT
• 00818524020035: PERFECTO MONOPHASE SHM TUBE KIT
• 00818524020028: PERFECTO HEAVY BODY SHM TUBE KIT
• 10818524020018: PERFECTO MONOPHASE SHM REGULAR/SET 2 PACK CARTRIDGE KIT
• 10818524020001: PERFECTO HEAVY BODY SHM FAST SET 2 PACK CARTRIDGE KIT