AccessGUDID - DEVICE: LeFlap DuJour (B698LFDJ880)

GUDID

Device Identifier (DI) Information

Brand Name: LeFlap DuJour
Version or Model: 88
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LFDJ88
Company Name: MONARCH LABS

Primary DI Number: B698LFDJ880
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796813009 *Terms of Use

Device Description: LeFlap Dujour is a sterile, single-piece, hinged hydrocolloid and polyester net dressing for use to confine Medical Maggots. This model is 8" x 8" square, but can be cut to any smaller size and shape

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):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQK	Maggots, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072438	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Inch
Width: 8 Inch

Device Record Status

Public Device Record Key: dfe0cedc-97ed-4c24-b0f0-968cc90c8873
Public Version Date: June 28, 2019
Public Version Number: 1
DI Record Publish Date: June 20, 2019