LeFlap DuJour LFDJ44

GUDID B698LFDJ440

LeFlap DuJour is a sterile, single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. This model is 4" x 4" square, but can be cut to any smaller size and shape.

MONARCH LABS

Wound debridement maggot cover

• Primary Device ID: B698LFDJ440
• NIH Device Record Key: 5c8c1afd-a5ff-45ff-82e3-962ea347a7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeFlap DuJour
• Version Model Number: 44
• Catalog Number: LFDJ44
• Company DUNS: 796813009
• Company Name: MONARCH LABS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9496793000
• Email: jsherman@monarchlabs.com

Device Dimensions

• Width: 4 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B698LFDJ440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072438

FDA Product Code

• NQK: Maggots, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [LeFlap DuJour]

• B698LFDJ880: LeFlap Dujour is a sterile, single-piece, hinged hydrocolloid and polyester net dressing for use
• B698LFDJ440: LeFlap DuJour is a sterile, single-piece, hinged hydrocolloid and polyester net dressing for use