FDA UDI
In Commercial Distribution
🇺🇸 United States
Medicinal Maggots
DI: B698MM2501
·
Model: 250
·
MONARCH LABS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Medicinal Maggots
- Primary DI
- B698MM2501
- Version / Model
- 250
- Catalog Number
- MM250
- Company Name
- MONARCH LABS
- Labeler DUNS
- 796813009
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-24
- Public Version
- 1
- Public Version Date
- 2023-05-02
- Public Version Status
- New
- Public Device Record Key
- bbd82db6-5ee3-4b5e-b5ad-5d0ed6899e2c
Device Description
Maggot-impregnated gauze. Two 2" x 2" gauze pads impregnated with 250 - 500 disinfected larvae.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 64283 | Wound debridement maggot | A medicinal maggot (fly larva) intended to be used in the home or healthcare facility for biotherapeutic debridement of chronic wounds (e.g., pressure ulcer, neuropathic foot ulcer, postsurgical wound). It may be available as free maggots or as maggot-impregnated gauze applied to the wound; it may be accompanied by a dedicated covering to confine maggots to the wound, along with additional accessory items (e.g., tape, sterile gauze). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B698MM2501 | HIBCC |
Customer Contacts
- Phone
- 949-679-3000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072438 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit