Spooled Nitanium

GUDID 00190707101039

.016 SPOOLED NITANIUM 10ft

ORTHO ORGANIZERS, INC.

Orthodontic archwire

• Primary Device ID: 00190707101039
• NIH Device Record Key: e2b66968-12fb-4169-8f3d-2ff9c6b79c3f
• Commercial Distribution Discontinuation: 2025-02-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Spooled Nitanium
• Version Model Number: 100-896
• 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: 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	00190707101039 [Primary]

FDA Product Code

• DZC: WIRE, 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: 2025-03-03
• Device Publish Date: 2022-01-06

On-Brand Devices [Spooled Nitanium]

• 00190707101046: .018 SPOOLED NITANIUM 10ft
• 00190707101039: .016 SPOOLED NITANIUM 10ft