StatGuard Hemostatic Dressing, Regular 480-3020-20

GUDID 10815614020828

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 an 8 cm x 10 cm adhesive dressing

SEMLER TECHNOLOGIES, INC.

Chitosan haemostatic agent, professional

• Primary Device ID: 10815614020828
• NIH Device Record Key: d24083d9-aff6-4ed5-8680-c07deb7ef18b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatGuard Hemostatic Dressing, Regular
• Version Model Number: 3020-20
• Catalog Number: 480-3020-20
• 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	10815614020828 [Primary]
GS1	20815614020825 [Package]; Package: Box [20 Units]; In Commercial Distribution
GS1	30815614020822 [Package]; Contains: 20815614020825; 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: 2019-02-28

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