AccessGUDID - DEVICE: Activon Tube (05060031471182)

GUDID

Device Identifier (DI) Information

Brand Name: Activon Tube
Version or Model: CR3830
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BRIGHTWAKE LIMITED

Primary DI Number: 05060031471182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 226502201 *Terms of Use

Device Description: 100% Medical Grade Manuka honey. Activon Tube contains 100% Medical Grade Manuka honey with no additives. This wound filler will eliminate odors and provides a moist wound healing environment that facilitates autolytic debridement. Activon Tube can be used as a wound filler for use in cavities.

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):	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?
47773	Medical honey liquid barrier dressing	A material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101114	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
Weight: 25 Gram

Device Record Status

Public Device Record Key: a58ce630-174a-47b2-8ad5-d3a1865c2440
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: July 27, 2023