Stainless Steel Standard Twist Archwire

GUDID 00190707102814

0215 14" STRAIGHT TWIST (20)

ORTHO ORGANIZERS, INC.

Orthodontic archwire

• Primary Device ID: 00190707102814
• NIH Device Record Key: 72946dae-be4a-4f8b-95c9-d12e632d8973
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stainless Steel Standard Twist Archwire
• Version Model Number: 100-211
• 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	00190707102814 [Primary]

FDA Product Code

• DZC: WIRE, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-25
• Device Publish Date: 2022-10-17

On-Brand Devices [Stainless Steel Standard Twist Archwire]

• 00190707102814: 0215 14" STRAIGHT TWIST (20)
• 00190707100100: .0195 Stainless Steel Standard Twist Archwire