AccessGUDID - DEVICE: Omni-stat Hemostatic Gauze (15060206630595)

GUDID

Device Identifier (DI) Information

Brand Name: Omni-stat Hemostatic Gauze
Version or Model: FG07734331
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG07734331
Company Name: MEDTRADE PRODUCTS LIMITED

Primary DI Number: 15060206630595
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 238476068 *Terms of Use

Device Description: Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderate to severe bleeding Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only

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?
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
Width: 17 Millimeter
Length: 120 Millimeter
Device Size Text, specify: Supplied folded size 17mm by 60mm

Device Record Status

Public Device Record Key: 802d279c-0ea5-44b8-81ae-04de5d2040e2
Public Version Date: January 20, 2025
Public Version Number: 3
DI Record Publish Date: January 17, 2020