MECRON Hip-Spica U: 105-125 cm 38-820L

GUDID 10609271950198

L White left

DARCO INTERNATIONAL, INC.

Hip orthosis

• Primary Device ID: 10609271950198
• NIH Device Record Key: d6da6de1-2138-4737-a7ed-e04e14ca1f44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MECRON Hip-Spica U: 105-125 cm
• Version Model Number: 38-820L
• Catalog Number: 38-820L
• 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	00609271950191 [Primary]
GS1	10609271950198 [Package]; Contains: 00609271950191; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• IQI: ORTHOSIS, LIMB BRACE

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

On-Brand Devices [MECRON Hip-Spica U: 105-125 cm]

• 10609271950204: L White right
• 10609271950198: L White left
• 10609271950181: L White double-sided