Creature Comforts

Basic Information

• Brand Name: Creature Comforts
• Primary DI: B698CC880
• Version / Model: 88
• Catalog Number: CC88
• Company Name: MONARCH LABS
• Labeler DUNS: 796813009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-20
• Public Version: 1
• Public Version Date: 2019-06-28
• Public Version Status: New
• Public Device Record Key: cf37a17b-ff8e-448b-8057-95c6fdf578df

Device Description

Polyester net (fixed-wave, 160 micron pore size) to be used as a dressing for Medical Maggots 8" x 8"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQK	Maggots, Medical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
64284	Wound debridement maggot cover	A wound covering intended to help confine medicinal maggots (fly larvae) to a chronic wound [e.g., pressure ulcer, neuropathic foot ulcer, postsurgical wound] for biotherapeutic debridement; it has no direct wound healing/protection intended uses. It is available in various materials (e.g., hydrocolloid, polyester), sizes, and designs [e.g., adhesive backing, tubular structure] to accommodate wound size and anatomical location. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B698CC880	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K033391	000

Device Sizes

Type	Value	Unit	Text
Length	8	Inch
Width	8	Inch