LeFlap DuJour LFDJ88

GUDID B698LFDJ880

LeFlap Dujour is a sterile, single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. This model is 8" x 8" square, but can be cut to any smaller size and shape

MONARCH LABS

Wound debridement maggot cover

• Primary Device ID: B698LFDJ880
• NIH Device Record Key: dfe0cedc-97ed-4c24-b0f0-968cc90c8873
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeFlap DuJour
• Version Model Number: 88
• Catalog Number: LFDJ88
• 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: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B698LFDJ880 [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