Creature Comfort CC1212

GUDID B698CC12120

Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medical Maggots 12" x 12"

MONARCH LABS

Wound debridement maggot cover

• Primary Device ID: B698CC12120
• NIH Device Record Key: 1eddfcf4-1212-4e06-bd81-e7d723b7fdf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creature Comfort
• Version Model Number: 1212
• Catalog Number: CC1212
• 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: 12 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B698CC12120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033391

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

Devices Manufactured by MONARCH LABS

• B698CC12121 - Sheer Comfort: 2023-05-02 Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medicinal Maggots 12" x 12"
• B698CC24241 - Sheer Comfort: 2023-05-02 Polyester net (fixed-weave, 160 microns pore size) to be used as a dressing for Medicinal Maggots 24" x 24"
• B698CC441 - Sheer Comfort: 2023-05-02 Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medicinal Maggots. 4" x 4."
• B698CC881 - Sheer Comfort: 2023-05-02 Polyester net (fixed-wave, 160 micron pore size) to be used as a dressing for Medicinal Maggots 8" x 8"
• B698CCKH1 - Sheer Comfort: 2023-05-02 Sterile knee-high nylon stockings with elastic mesh, for use in confining Medicinal Maggots to stump, heal, and other non-planer
• B698CCPH1 - Sheer Comfort: 2023-05-02 Sterile Panty Hose nylon stockings with elastic mesh, for use in confining Medicinal Maggots to stump, heal, and other non-plane
• B698MM2501 - Medicinal Maggots: 2023-05-02 Maggot-impregnated gauze. Two 2" x 2" gauze pads impregnated with 250 - 500 disinfected larvae.
• B698CC12120 - Creature Comfort: 2019-06-28Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medical Maggots 12" x 12"
• B698CC12120 - Creature Comfort: 2019-06-28 Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medical Maggots 12" x 12"