Direct Bond Lingual Sheath

GUDID 00190707096991

.036 Direct Bond Lingual Sheath

Ortho Organizers, Inc.

Orthodontic bracket, metal

• Primary Device ID: 00190707096991
• NIH Device Record Key: e5d81e8f-8084-4c7a-8fa8-8d10a8d020bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Bond Lingual Sheath
• Version Model Number: 971-032DB
• 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: true
• Expiration Date: false
• 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	00190707096991 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, 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

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