ORTHOCHEWIE 60.20.1003

GUDID 07908611206053

ORTHOCHEWIE FOR ALIGNERS

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use Orthodontic aligner/retainer seater, single-use

• Primary Device ID: 07908611206053
• NIH Device Record Key: f13835fb-1ec7-4247-8706-649152119b12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOCHEWIE
• Version Model Number: 60.20.1003
• Catalog Number: 60.20.1003
• Company DUNS: 898330003
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07908611206053 [Primary]

FDA Product Code

• ECS: Pusher, Band, 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: 2024-03-06
• Device Publish Date: 2024-02-27

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

• 07908611210029 - PROMO KIT ADVANCED ROTH 0.022": 2024-04-24 PROMO KIT ADVANCED ROTH 0.022" - (5X5) + 40 MOLAR TUBES + NITI SE 0.014"
• 07908611210036 - PROMO KIT ADVANCED ROTH 0.022": 2024-04-24 PROMO KIT ADVANCED ROTH 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014 ALX
• 07908611210043 - PROMO KIT ADVANCED MBT 0.022": 2024-04-24 PROMO KIT ADVANCED MBT 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014"
• 07908611210050 - PROMO KIT ADVANCED MBT 0.022": 2024-04-24 PROMO KIT ADVANCED MBT 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014" ALX
• 07908611210067 - PROMO KIT ICERAM-P ROTH 0.022: 2024-04-24 PROMO KIT ICERAM-P ROTH 0.022 – 03 KITS (5X5) + 01 BRACKET REMOVAL PLIER
• 07908611210074 - PROMO KIT ICERAM-P MBT 0.022": 2024-04-24 PROMO KIT ICERAM-P MBT 0.022" – 03 KITS (5X5) + 01 BRACKET REMOVAL PLIER
• 07908611210081 - PROMO KIT ICERAM CLASS II CORRECTOR 23MM: 2024-04-24 PROMO KIT ICERAM CLASS II CORRECTOR 23MM (2UN) + MINI TUBO ICERAM (2UN)
• 07908611210098 - PROMO KIT ICERAM CLASS II CORRECTOR 25MM: 2024-04-24 PROMO KIT ICERAM CLASS II CORRECTOR 25MM (2UN) + MINI TUBO ICERAM (2UN)