AccessGUDID - DEVICE: Curaplex Advanced Hemostatic Gauze (01999720000041)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex Advanced Hemostatic Gauze
Version or Model: 3in x 3.2Yds (7.6cm x 300 cm)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CAHG-Z10
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 01999720000041
Issuing Agency: GS1
Commercial Distribution End Date: May 01, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Hemostatic Gauze, Z-Fold, 3 IN X 3.2 YD

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?
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
QSY	Hemostatic wound dressing without thrombin or other biologics

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: Yes

Sterilization Method [?]
Radiation Sterilization

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: fc2f0f16-57b2-4b43-9d99-ce19143753eb
Public Version Date: May 04, 2026
Public Version Number: 2
DI Record Publish Date: November 25, 2025