STFR Radial Patch

GUDID 10862499000261

Topical hemostatic pad

Chitogen Inc

Wound-nonadherent dressing, permeable, non-antimicrobial

• Primary Device ID: 10862499000261
• NIH Device Record Key: 9c1cd7bd-f315-44b5-81b1-d0142dfec31a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STFR Radial Patch
• Version Model Number: 2160
• Company DUNS: 010307324
• Company Name: Chitogen 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch
• Length: 1.25 Inch
• Width: 1.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862499000264 [Primary]
GS1	10862499000261 [Package]; Contains: 00862499000264; Package: Box [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090100

FDA Product Code

• QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by Chitogen Inc

• 10862499000261 - STFR Radial Patch: 2024-03-26Topical hemostatic pad
• 10862499000261 - STFR Radial Patch: 2024-03-26 Topical hemostatic pad
• 00862499000202 - SoftSeal: 2020-11-06 Topical hemostatic pad
• 10862499000254 - D-SEAL: 2020-11-06 hemostatic dressing