Sheer Comfort CCKH

GUDID B698CCKH1

Sterile knee-high nylon stockings with elastic mesh, for use in confining Medicinal Maggots to stump, heal, and other non-planer wounds.

MONARCH LABS

Wound debridement maggot cover

• Primary Device ID: B698CCKH1
• NIH Device Record Key: c14484bd-753e-434b-a493-325c2f31d3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheer Comfort
• Version Model Number: KH
• Catalog Number: CCKH
• 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: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com
• Phone: 9496793000
• Email: jkuo@monarchlabs.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B698CCKH1 [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: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [Sheer Comfort]

• B698CCPH1: Sterile Panty Hose nylon stockings with elastic mesh, for use in confining Medicinal Maggots to
• B698CCKH1: Sterile knee-high nylon stockings with elastic mesh, for use in confining Medicinal Maggots to s
• B698CC881: Polyester net (fixed-wave, 160 micron pore size) to be used as a dressing for Medicinal Maggots
• B698CC441: Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medicinal Maggots
• B698CC24241: Polyester net (fixed-weave, 160 microns pore size) to be used as a dressing for Medicinal Maggot
• B698CC12121: Polyester net (fixed-weave, 160 micron pore size) to be used as a dressing for Medicinal Maggots