MECRON Torso MaBanfertigung M4200

GUDID 10609271951423

Torso

DARCO INTERNATIONAL, INC.

Lumbar spine orthosis

• Primary Device ID: 10609271951423
• NIH Device Record Key: fd3bf733-bd11-47e4-aa67-ffd60f9df173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MECRON Torso MaBanfertigung
• Version Model Number: M4200
• Catalog Number: M4200
• Company DUNS: 184231298
• Company Name: DARCO INTERNATIONAL, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00609271951426 [Primary]
GS1	10609271951423 [Package]; Contains: 00609271951426; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• IPX: ORTHOSIS, RIB FRACTURE, SOFT

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: 2023-02-22
• Device Publish Date: 2023-02-14

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• 00609271120228 - POGO™ Pulsus: 2025-04-23 Therapeutic Shoe, Navy, Men's 8.0 / Women's 9.5
• 00609271120235 - POGO™ Pulsus: 2025-04-23 Therapeutic Shoe, Navy, Men's 8.5 / Women's 10