MECRON Torso Sonderanfertigung S4200

GUDID 10609271952604

Torso

DARCO INTERNATIONAL, INC.

Lumbar spine orthosis

• Primary Device ID: 10609271952604
• NIH Device Record Key: 28d59ce1-935c-4240-bb8d-4a74b053d387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MECRON Torso Sonderanfertigung
• Version Model Number: S4200
• Catalog Number: S4200
• 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	00609271952607 [Primary]
GS1	10609271952604 [Package]; Contains: 00609271952607; 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

Devices Manufactured by DARCO INTERNATIONAL, INC.

• 20609271989607 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 4.5 / Women's 6.0)
• 20609271989614 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 5.5 / Women's 7.0)
• 20609271989621 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 6.0 / Women's 7.5 )
• 20609271989638 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 6.5 / Women's 8.0)
• 00609271989641 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 7.0 / Women's 8.5 )
• 20609271989652 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 7.5 / Women's 9.0)
• 20609271989669 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 8.0 / Women's 9.5 )
• 20609271989676 - Aircore™ Insole: 2026-01-15 Peg Off-Loading Insole for POGO® (Men's 8.5 / Women's 10 )