Smile Safari™ Clear Elastic

GUDID 00190707097196

Smile Safari™ Clear Elastic Medium 5/16 (4.5oz)-Gorilla

Ortho Organizers, Inc.

Orthodontic inter-arch elastic band

• Primary Device ID: 00190707097196
• NIH Device Record Key: 33a0ddca-2ec7-463b-bce2-97574204d7f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smile Safari™ Clear Elastic
• Version Model Number: 401-064S
• Company DUNS: 062165188
• Company Name: Ortho Organizers, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00190707097196 [Primary]

FDA Product Code

• ECI: BAND, ELASTIC, ORTHODONTIC

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: 2025-12-19
• Device Publish Date: 2022-01-06

On-Brand Devices [Smile Safari™ Clear Elastic]

• 00190707097202: Smile Safari™ Clear Elastic Medium 3/8 (4.5oz)-Warthog
• 00190707097196: Smile Safari™ Clear Elastic Medium 5/16 (4.5oz)-Gorilla
• 00190707097189: Smile Safari™ Clear Elastic Medium 1/4 (4.5oz)-Lion
• 00190707097172: Smile Safari™ Clear Elastic Medium 3/16 (4.5oz)-Zebra
• 00190707097165: Smile Safari™ Clear Elastic Medium 1/8 (4.5oz)-Chimpanzee