Lotus Plus®

GUDID 00190730084774

Lotus Plus® Closing and Archwires Director Tweezers

ORTHO TECHNOLOGY, INC.

Orthodontic ligature director

• Primary Device ID: 00190730084774
• NIH Device Record Key: 9f552cde-d71e-4dca-9b6c-6d32a20ca59d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lotus Plus®
• Version Model Number: OT-211
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00190730084774 [Primary]

FDA Product Code

• DZN: INSTRUMENTS, DENTAL HAND

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: 2024-09-25
• Device Publish Date: 2024-09-17

Devices Manufactured by ORTHO TECHNOLOGY, INC.

• 10190730084535 - Clear Advantage: 2025-08-01 Splint Material .020“ 50 sheets per pack
• 10190730084542 - Clear Advantage: 2025-08-01 Splint Material .030“ – FOIL packaging of 50
• 10190730084559 - Clear Advantage: 2025-08-01 Splint Material .040“ 50 sheets per pack
• 10190730084566 - Clear Advantage: 2025-08-01 Splint Material .060“ – FOIL packaging of 25
• 10190730084573 - Clear Advantage: 2025-08-01 Splint Material .080“ 25 sheets per pack
• 10190730084580 - Sports Advantage: 2025-08-01 Mouthguard Plastic Clear .080“ 25 sheets per pack
• 10190730084597 - Sports Advantage: 2025-08-01 Mouthguard Plastic Clear .040“ 25 sheets per pack
• 00190730084682 - Ortho Technology: 2024-09-26 Boone Gauge Stainless Steel