AccessGUDID - DEVICE: CELOX Gauze Z-Fold (15060206631394)

GUDID

Device Identifier (DI) Information

Brand Name: CELOX Gauze Z-Fold
Version or Model: FG08838181
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG08838181
Company Name: MEDTRADE PRODUCTS LIMITED

Primary DI Number: 15060206631394
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 238476068 *Terms of Use

Device Description: Hemostatic Z-Fold Gauze - Non-woven gauze coated with Celox hemostatic granules. The dressing is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions. For use by trained emergency responders.

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):	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?
46922	Chitosan haemostatic agent, professional, non-bioabsorbable	A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied exclusively by healthcare professionals in a clinical setting to traumatic wounds in emergency situations (e.g., road accidents, combat, emergency rescue) or during surgical intervention to produce a rapid haemostasis by forming a robust plug of gel which is removed after use. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). 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 [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 3in x 5ft Z-folded
Length: 5 Feet
Width: 3 Inch

Device Record Status

Public Device Record Key: 509785fb-c4ab-4a44-a633-0a3db40d8b96
Public Version Date: January 20, 2025
Public Version Number: 2
DI Record Publish Date: August 31, 2022