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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
Sterile Panty Hose nylon stockings with elastic mesh, for use in confining Medicinal Maggots to stump, heal, and other non-planer wounds. FDA UDI
Model / Reference
PH FDA UDI
Description
Sterile Panty Hose nylon stockings with elastic mesh, for use in confining Medicinal Maggots to stump, heal, and other non-planer wounds. FDA UDI

Identifiers

Catalog Number
CCPH FDA UDI
Primary DI / UDI-DI
B698CCPH1 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

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 5dab7c57-983a-46c3-a90a-656e281c6edd 37 fields · synced May 30, 2026