FDA.reportPublic FDA data

Sheer Comfort

Primary DI
B698CC881
Brand
Sheer Comfort
Company
MONARCH LABS
Model
88
Catalog number
CC88
Device description
"Polyester net (fixed-wave, 160 micron pore size) to be used as a dressing for Medicinal Maggots 8"" x 8"""
Published
2023-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQKMaggots, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQKMaggots, MedicalUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072438000MEDICAL MAGGOTS, CREATURE COMFORTSMonarch Labs, LLC2007-10-05NQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B698CC881PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound debridement maggot coverA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Width8Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9496793000jkuo@monarchlabs.com

Regulatory Flags#

DUNS number
796813009
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B698CC12121Sheer Comfort1212CC12122023-04-24
B698CC24241Sheer Comfort2424CC24242023-04-24
B698CC441Sheer Comfort44CC442023-04-24
B698CCKH1Sheer ComfortKHCCKH2023-04-24
B698CCPH1Sheer ComfortPHCCPH2023-04-24
B698MM2501Medicinal Maggots250MM2502023-04-24
B698CC12120Creature Comfort1212CC12122019-06-20
B698CC24240Creature Comforts2424CC24242019-06-20
B698CC440Creature Comforts44CC442019-06-20
B698CC880Creature Comforts88CC882019-06-20
B698CCKH0Creature ComfortsKHCCKH2019-06-20
B698CCPH0Creature ComfortsPHCCPH2019-06-20
B698LF330LeFlap33LF332019-06-20
B698LF660LeFlap66LF662019-06-20
B698LFDJ440LeFlap DuJour44LFDJ442019-06-20
B698LFDJ880LeFlap DuJour88LFDJ882019-06-20
B698LS12X180LeSoc12x18LS 12x182019-06-20
B698LS18X240LeSoc18x24LS 18x242019-06-20
B698LS24X360LeSoc24x36LS 24x362019-06-20
B698LS2X30LeSoc2X3LS2X32019-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B698CC12121Sheer ComfortMONARCH LABSNQK2023-04-24
B698CC24241Sheer ComfortMONARCH LABSNQK2023-04-24
B698CC441Sheer ComfortMONARCH LABSNQK2023-04-24
B698CCKH1Sheer ComfortMONARCH LABSNQK2023-04-24
B698CCPH1Sheer ComfortMONARCH LABSNQK2023-04-24
B698MM2501Medicinal MaggotsMONARCH LABSNQK2023-04-24
B698CC12120Creature ComfortMONARCH LABSNQK2019-06-20
B698CC24240Creature ComfortsMONARCH LABSNQK2019-06-20
B698CC440Creature ComfortsMONARCH LABSNQK2019-06-20
B698CC880Creature ComfortsMONARCH LABSNQK2019-06-20
B698CCKH0Creature ComfortsMONARCH LABSNQK2019-06-20
B698CCPH0Creature ComfortsMONARCH LABSNQK2019-06-20
B698LF330LeFlapMONARCH LABSNQK2019-06-20
B698LF660LeFlapMONARCH LABSNQK2019-06-20
B698LFDJ440LeFlap DuJourMONARCH LABSNQK2019-06-20
B698LFDJ880LeFlap DuJourMONARCH LABSNQK2019-06-20
B698LS12X180LeSocMONARCH LABSNQK2019-06-20
B698LS18X240LeSocMONARCH LABSNQK2019-06-20
B698LS24X360LeSocMONARCH LABSNQK2019-06-20
B698LS2X30LeSocMONARCH LABSNQK2019-06-20
B698LS4X60LeSocMONARCH LABSNQK2019-06-20
B698LS6X80LeSocMONARCH LABSNQK2019-06-20
B698LS8X120LeSocMONARCH LABSNQK2019-06-20
B698MM2500Medical MaggotsMONARCH LABSNQK2019-06-20