LeFlap LF66

GUDID B698LF660

LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots 6" x 6".

MONARCH LABS

Wound debridement maggot cover

• Primary Device ID: B698LF660
• NIH Device Record Key: a2f22371-4851-43b1-96ae-462bbe42a554
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeFlap
• Version Model Number: 66
• Catalog Number: LF66
• 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: 6 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B698LF660 [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]

• B698LF660: LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to
• B698LF330: LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to