StatGuard Hemostatic Patch 480-3010-00

GUDID 30815614020808

The StatGuard Hemostatic Patch is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision following to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation.

SEMLER TECHNOLOGIES, INC.

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• Primary Device ID: 30815614020808
• NIH Device Record Key: b97fc98b-4d65-402a-92c9-6e93e73c5bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatGuard Hemostatic Patch
• Version Model Number: 3010-00
• Catalog Number: 480-3010-00
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020804 [Primary]
GS1	20815614020801 [Package]; Contains: 10815614020804; Package: Box [20 Units]; In Commercial Distribution
GS1	30815614020808 [Package]; Contains: 20815614020801; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172155

FDA Product Code

• FRO: Dressing, Wound, Drug
• 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-03-10
• Device Publish Date: 2019-08-07

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