Blu-Mousse® S437S

GUDID M595S437S1

Peppermint Classic Blu-Mousse® In Split-Cartridge System

PARKELL, INC.

Silicone dental impression material

• Primary Device ID: M595S437S1
• NIH Device Record Key: 7b788178-13a5-441f-a8d0-3f45b6453b96
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Blu-Mousse®
• Version Model Number: S437S
• Catalog Number: S437S
• Company DUNS: 009900424
• Company Name: PARKELL, 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: 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

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S437S0 [Primary]
HIBCC	M595S437S1 [Package]; Contains: M595S437S0; Package: [2 Units]; Discontinued: 2019-01-01; Not 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: 3
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-23

On-Brand Devices [Blu-Mousse®]

• M595S4360: Tubes of Classic Blu-Mousse®
• M595S4571: Super-Fast Blu-Mousse® Standard-Cartridge System
• M595S448S1: Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System
• M595S440S1: Blu-Mousse® 60 In Split-Cartridge
• M595S4381: Classic Blu-Mousse® Standard-Cartridge System
• M595S437S1: Peppermint Classic Blu-Mousse® In Split-Cartridge System
• M595S457S0: Super-Fast Blu-Mousse® Split-Cartridge System
• M595S438S0: Classic Blu-Mousse® In Split-Cartridge System
• 00810000524211: Super-Fast Blu-Mousse® Standard-Cartridge System (Korea)
• 00810000524167: Classic Blu-Mousse® in Standard Cartridges (Korea)
• 00810000524228: Super-Fast Blu-Mousse® Split-Cartridge System (Korea)
• 00810000524181: Blu-Mousse® 60 In Split-Cartridge (Korea)
• 00810000524174: Classic Blu-Mousse® In Split-Cartridge System (Korea)
• 00810000524501: Tubes of Classic Blu-Mousse® (Korea)
• 10810000526984: Mixing Tip for Standard Cartridge for use with Blu-Mousse® (Pkg. of 30 pcs.)
• 10810000526977: Snap-In Intraoral Tip for Use in S439K, S445 & S496 Mixing Tips (Pkg. of 50 pcs.)
• 10810000524218: Super-Fast Blu-Mousse® Standard-Cartridge System
• 10810000524164: Classic Blu-Mousse® Cartridges
• 10810000524195: Peppermint Super-Fast Blu-Mousse® In Split-Cartridge System
• 10810000524188: Blu-Mousse® 60 In Split-Cartridge
• 10810000524157: Peppermint Classic Blu-Mousse® In Split-Cartridge System