EXTRA-ORAL ELASTIC 8 OZ 1/2" NO MINT FLAVOR

GUDID 07908611211316

EXTRA-ORAL ELASTIC 8 OZ 1/2" NO MINT FLAVOR

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic inter-arch elastic band

• Primary Device ID: 07908611211316
• NIH Device Record Key: 025b5b7b-be3e-4bd2-a003-70c5c2d4cef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXTRA-ORAL ELASTIC 8 OZ 1/2" NO MINT FLAVOR
• Version Model Number: 60.01.1201
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07908611211316 [Primary]

FDA Product Code

• ECI: Band, Elastic, 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: 2025-02-04
• Device Publish Date: 2025-01-27

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

• 07908611211507 - METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS: 2025-09-05 METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS
• 07908611210333 - ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR: 2025-04-15 1 SET ICERAM-P MBT 0.022 1 PAIR OF ESTHETIC ARCHWIRES 1 PEARL BLUE MODULAR
• 07908611210340 - ICERAM-P MBT 0.022 KIT – 5 SETS + 1 FREE MIXED ORTHODONTIC MANNEQUIN: 2025-04-15 ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM
• 07908611211163 - PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR: 2025-04-15 PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE
• 07908611211170 - PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR: 2025-04-15 PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE
• 07908611211200 - BUTTON WITH HOOK MJANSON: 2025-04-15 BUTTON WITH HOOK BONDING MJANSON
• 07908611211217 - ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK: 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK
• 07908611211224 - ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK: 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK