FDA.reportPublic FDA data

Creature Comforts

Primary DI
B698CCPH0
Brand
Creature Comforts
Company
MONARCH LABS
Model
PH
Catalog number
CCPH
Device description
Sterile Panty Hose nylon stockings with elastic mesh, for use in confining Medical Maggots to stump, heal, and other non-planer wounds.
Published
2019-06-20
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
K033391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033391000MEDICAL MAGGOTSRonald A. Sherman2004-01-12NQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B698CCPH0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9496793000jsherman@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
B698CC881Sheer Comfort88CC882023-04-24
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
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
B698CC881Sheer 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
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