OPENING TOOL 800-146

GUDID D90980014616

ECLIPSE SLB OPENING TOOL

Ortho Arch Company Inc

Orthodontic pliers

• Primary Device ID: D90980014616
• NIH Device Record Key: 7300b057-cf46-4db9-80f3-86d97d17e0dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPENING TOOL
• Version Model Number: 800-146
• Catalog Number: 800-146
• Company DUNS: 020956330
• Company Name: Ortho Arch Company Inc
• Device Count: 1
• DM Exempt: false
• 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: false
• 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
HIBCC	D90980014616 [Primary]

FDA Product Code

• JEX: Plier, 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: 2023-07-06
• Device Publish Date: 2023-06-28

Devices Manufactured by Ortho Arch Company Inc

• D90970000913 - ORTHO ARCH: 2025-09-05 WIRE BONDER SMALL TIPS & HANDLE (10 TIPS)
• D9097000111 - ORTHO ARCH: 2025-09-05 BRACKET BONDER TIPS & HANDLE (10 TIPS)
• D9097001011 - ORTHO ARCH: 2025-09-05 MINI MOLD INTRO KIT
• D9097001021 - ORTHO ARCH: 2025-09-05 Mini Mold Universal Bite Opening Kit
• D90970010M1 - ORTHO ARCH: 2025-09-05 MINI MOLD STARTER KIT 30 TIPS
• D9097001111 - ORTHO ARCH: 2025-09-05 MINI MOLD PEG LATERAL 4 TIP KIT
• D90970011511 - ORTHO ARCH: 2025-09-05 ANTERIOR BITE JET 7MM TIPS (8)
• D90970011713 - ORTHO ARCH: 2025-09-05 ANTERIOR BITE RAMP 3MM TIPS & HANDLE (8)