Pink Silicast 10302

GUDID 00850047788184

Pink Silicast Impression Material - two 525g tubs

Westone Laboratories, Inc.

Earmould impression material

• Primary Device ID: 00850047788184
• NIH Device Record Key: 8bf02f3e-24c5-4fd4-8209-2c61c0c0c2e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pink Silicast
• Version Model Number: NA
• Catalog Number: 10302
• Company DUNS: 007087497
• Company Name: Westone Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850047788184 [Primary]

FDA Product Code

• LDG: Kit, Earmold, 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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [Pink Silicast]

• 00850047788184: Pink Silicast Impression Material - two 525g tubs
• 00850047788177: Pink Silicast Impression Material - two 335g tubs