FDA UDI
In Commercial Distribution
🇺🇸 United States
LeFlap
DI: B698LF330
·
Model: 33
·
MONARCH LABS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LeFlap
- Primary DI
- B698LF330
- Version / Model
- 33
- Catalog Number
- LF33
- Company Name
- MONARCH LABS
- Labeler DUNS
- 796813009
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-20
- Public Version
- 1
- Public Version Date
- 2019-06-28
- Public Version Status
- New
- Public Device Record Key
- cdba1d34-28f5-434b-9093-7c787395a5b0
Device Description
LeFlap Maggot Dressing - single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. 3" x 3."
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQK | Maggots, Medical | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64284 | Wound debridement maggot cover | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B698LF330 | HIBCC |
Customer Contacts
- Phone
- 9496793000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072438 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 3 | Inch | |
| Length | 3 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit