The First Years

GUDID B268Y52880

Star Teether

TOMY INTERNATIONAL, INC.

Teething device, fluid-filled

• Primary Device ID: B268Y52880
• NIH Device Record Key: d3f5f7f8-7547-41be-afd9-daf518584357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The First Years
• Version Model Number: Y5288
• 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	B268Y52281 [Package]; Package: Retail [1 Units]
HIBCC	B268Y52880 [Primary]
HIBCC	B268Y52886 [Package]; Contains: B268Y52281; Package: Inner Carton [6 Units]
HIBCC	B268Y52889 [Package]; Contains: B268Y52886; Package: Master Carton [4 Units]

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: 2017-02-11

On-Brand Devices [The First Years]

• B268Y70514: TFY Rapid Read Underarm Thermometer
• B268Y62281: Quiet Expressions breast pump with Breastflow bottle
• B268Y60531: Quiet Expressions Plus Rechargeable Pump - Double
• B268Y52880: Star Teether
• B268Y7078A61: Digital Thermometer
• B268Y7057A51: Health and Grooming Kit
• B268Y79571: Health and Grooming Kit
• B268Y7078A71: Multi-Use Digital Thermometer