HemCon® OneStop™ Bandage, 2in x 2in, OTC 1112

GUDID 00870053000360

OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulation therapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.

TRICOL BIOMEDICAL, INC.

Chitosan haemostatic agent, professional

• Primary Device ID: 00870053000360
• NIH Device Record Key: fb19ad8e-c9fd-49f4-b920-8cce715208c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HemCon® OneStop™ Bandage, 2in x 2in, OTC
• Version Model Number: 1
• Catalog Number: 1112
• Company DUNS: 080240553
• Company Name: TRICOL BIOMEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com
• Phone: 9712231000
• Email: sales@tricolbiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00870053000360 [Primary]
GS1	50870053000365 [Package]; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150916

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-13
• Device Publish Date: 2021-05-05

Devices Manufactured by TRICOL BIOMEDICAL, INC.

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• 20870053001033 - HemCon® Dental Dressing PRO, 10mm x 12mm: 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
• 20870053001118 - HemCon® Dental Dressing PRO, 1in x 3in: 2021-07-19 The HemCon Dental Dressing PRO is a chitosan-based oral wound dressing intended as a physical barrier for temporary protection o
• 00870053001268 - HemCon® Strip PRO, 1in x 4in: 2021-07-19 The HemCon® Strip PRO is a wound dressing manufactured from chitosan. When applied directly to the wound, the HemCon® Strip PR
• 00870053000117 - GuardaCare®XR Surgical, 4in x 4in, 8ply: 2021-07-16 HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, n
• 20870053000333 - HemCon® OneStop™ Bandage, 2in x 2in: 2021-05-13 The OneStop™ Bandage is a wound dressing manufactured from chitosan. When applied directly to the wound, the OneStop™ Bandag