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Sheer Comfort

FDA UDI

Class U (US FDA UDI)

by Monarch Labs, Llc.

Identity

Trade Name
Sheer Comfort FDA UDI
Generic Name
Wound debridement maggot cover FDA UDI
Device Name
Polyester net (fixed-weave, 160 microns pore size) to be used as a dressing for Medicinal Maggots 24" x 24" FDA UDI
Model / Reference
2424 FDA UDI
Description
Polyester net (fixed-weave, 160 microns pore size) to be used as a dressing for Medicinal Maggots 24" x 24" FDA UDI

Identifiers

Catalog Number
CC2424 FDA UDI
Primary DI / UDI-DI
B698CC24241 FDA UDI
510(k) Number
K072438 FDA UDI
FDA Product Code
NQK FDA UDI
GMDN Term
Wound debridement maggot cover FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 24 Inch FDA UDI
Length — 24 Inch FDA UDI

Category: Wound debridement maggot cover

Sheer Comfort by Monarch Labs, Llc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound debridement maggot cover.

Cleared under the same submission

K072438 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monarch Labs, Llc.

Sources (1)

  • FDA UDI cebc76f8-4df0-4e56-91cf-1aa3bf999d2c 37 fields · synced May 31, 2026