AccessGUDID - DEVICE: Medrull - Ultra Pore - Adhesive Wound Dressing (00860012220328)

GUDID

Device Identifier (DI) Information

Brand Name: Medrull - Ultra Pore - Adhesive Wound Dressing
Version or Model: Waterproof 5x7cm N5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Overseas Consensus LLC

Primary DI Number: 00860012220328
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 118986451 *Terms of Use

Device Description: Self-adhesive sterile absorbent dressing made of soft non woven materials, is designed for low to moderately exuding wounds, such as surgical wounds, cuts and abrasions.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
58301	Synthetic polymer semi-permeable film dressing, adhesive	A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMK	Device, Intravascular Catheter Securement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 7afe46be-3b4d-402c-924d-ad8f9140caf6
Public Version Date: April 25, 2025
Public Version Number: 1
DI Record Publish Date: April 17, 2025