GuardaCare®XR Surgical, 4in x 4in, 8ply

Basic Information

• Brand Name: GuardaCare®XR Surgical, 4in x 4in, 8ply
• Primary DI: 00870053000117
• Version / Model: 1
• Catalog Number: 1032
• Company Name: TRICOL BIOMEDICAL, INC.
• Labeler DUNS: 080240553
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-08
• Public Version: 1
• Public Version Date: 2021-07-16
• Public Version Status: New
• Public Device Record Key: be91851d-7907-41ee-917f-be0628150827

Device Description

HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46922	Chitosan haemostatic agent, professional	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00870053000117	GS1
Package	20870053000111	GS1	Box	10	In Commercial Distribution
Package	50870053000112	GS1	Case	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103641	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 11 – 26 Degrees Celsius