MECRON Belt B: 22 cm, U: 84-110 cm 38-7330

GUDID 10609271950112

M White 3-tape bandage

DARCO INTERNATIONAL, INC.

Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable Abdominal binder, reusable

• Primary Device ID: 10609271950112
• NIH Device Record Key: d6de0963-0e44-45b6-a971-2333b3923033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MECRON Belt B: 22 cm, U: 84-110 cm
• Version Model Number: 38-7330
• Catalog Number: 38-7330
• 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	00609271950115 [Primary]
GS1	10609271950112 [Package]; Contains: 00609271950115; 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.

• 20609271040025 - Body Armor® Stirrup Walker: 2023-11-10 Tall, white (medium)
• 10609271040035 - Body Armor® Stirrup Walker: 2023-11-10 Tall, white (large)
• 20609271040049 - Body Armor® Stirrup Walker: 2023-11-10 Tall, white (x-large)
• 10609271040226 - Body Armor® Stirrup Walker: 2023-11-10 Tall, gray (medium)
• 10609271040233 - Body Armor® Stirrup Walker: 2023-11-10 Tall, gray (large)
• 20609271040247 - Body Armor® Stirrup Walker: 2023-11-10 Tall, gray (x-large)
• 10609271040004 - Body Armor® Stirrup Walker: 2023-10-02 Tall, white (x-small)
• 20609271040018 - Body Armor® Stirrup Walker: 2023-10-02 Tall, white (small)