Lamaze L27619

GUDID B268L276198

Water Filled Chill Teethers

TOMY INTERNATIONAL, INC.

Teething device, fluid-filled

• Primary Device ID: B268L276198
• NIH Device Record Key: 7c3fc839-46d7-4cf6-a244-cc0f680efc75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lamaze
• Version Model Number: L27619
• Catalog Number: L27619
• Company DUNS: 065183758
• Company Name: TOMY INTERNATIONAL, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B268L276190 [Primary]
HIBCC	B268L276192 [Package]; Contains: B268L276190; Package: Retail [2 Units]; In Commercial Distribution
HIBCC	B268L276198 [Package]; Contains: B268L276192; Package: Master [4 Units]; In Commercial Distribution
HIBCC	B268L276199 [Package]; Package: Master [3 Units]; In Commercial Distribution

FDA Product Code

• KKO: Ring, Teething, Fluid-Filled

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: 2019-09-13
• Device Publish Date: 2018-07-01

On-Brand Devices [Lamaze]

• B268L276198: Water Filled Chill Teethers
• B268Y5288L9: Teether