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LeFlap

FDA UDI

Class U (US FDA UDI)

by Monarch Labs, Llc.

Identity

Trade Name
LeFlap FDA UDI
Generic Name
Wound debridement maggot cover FDA UDI
Device Name
LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. 3" x 3." FDA UDI
Model / Reference
33 FDA UDI
Description
LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. 3" x 3." FDA UDI

Identifiers

Catalog Number
LF33 FDA UDI
Primary DI / UDI-DI
B698LF330 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 — 3 Inch FDA UDI
Length — 3 Inch FDA UDI

Category: Wound debridement maggot cover

LeFlap 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 cdba1d34-28f5-434b-9093-7c787395a5b0 38 fields · synced Jun 8, 2026