StatGuard Hemostatic Dressing, Small 480-3020-10

GUDID 10815614020811

The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in a 4 cm x 6 cm adhesive dressing.

SEMLER TECHNOLOGIES, INC.

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• Primary Device ID: 10815614020811
• NIH Device Record Key: 5ed00a78-a65a-4d46-9f43-974c3829e343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatGuard Hemostatic Dressing, Small
• Version Model Number: 3020-10
• Catalog Number: 480-3020-10
• 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	10815614020811 [Primary]
GS1	20815614020818 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	30815614020815 [Package]; Contains: 20815614020818; 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: 4
• Public Version Date: 2021-03-10
• Device Publish Date: 2018-09-27

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