Identity
- Trade Name
- LeSoc FDA UDI
- Generic Name
- Wound debridement maggot cover FDA UDI
- Device Name
- Fixed-weave polyester net bag-like (sock-like) dressing for confining Medical Maggots to a stump, finger, or other non-planar wound. 160 micron pore size. FDA UDI
- Model / Reference
- 2X3 FDA UDI
- Description
- Fixed-weave polyester net bag-like (sock-like) dressing for confining Medical Maggots to a stump, finger, or other non-planar wound. 160 micron pore size. FDA UDI
Identifiers
- Catalog Number
- LS2X3 FDA UDI
- Primary DI / UDI-DI
- B698LS2X30 FDA UDI
- 510(k) Number
- K102827 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
- Circumference — 3.5 Inch FDA UDIWidth — 1.75 Inch FDA UDILength — 2.5 Inch FDA UDI
Category: Wound debridement maggot cover
LeSoc by Monarch Labs, Llc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102827 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Monarch Labs, Llc.
Sources (1)
- FDA UDI af0cc07b-e3ed-4bcd-97c9-3de004503694 38 fields · synced May 30, 2026