AccessGUDID - DEVICE: Medical Maggots (B698MM2500)

GUDID

Device Identifier (DI) Information

Brand Name: Medical Maggots
Version or Model: 250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM250
Company Name: MONARCH LABS

Primary DI Number: B698MM2500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796813009 *Terms of Use

Device Description: Maggot-impregnated gauze. Two 2" x 2" gauze pads impregnated with 250 - 500 disinfected larvae.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQK	Maggots, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033391	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc2e381f-ac6a-4dbc-97e5-5978c33e1fb6
Public Version Date: June 28, 2019
Public Version Number: 1
DI Record Publish Date: June 20, 2019