NuStat

GUDID 00850392006155

NuStat 4x4

BEEKEN BIOMEDICAL LLC

Wound dressing kit, non-medicated

• Primary Device ID: 00850392006155
• NIH Device Record Key: c0f67809-18a5-4f50-ad36-2a2a5b75c4c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuStat
• Version Model Number: N-0404NT
• Company DUNS: 028807882
• Company Name: BEEKEN BIOMEDICAL LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392006155 [Primary]
GS1	10850392006152 [Package]; Package: Shelf Pack [50 Units]; In Commercial Distribution
GS1	20850392006159 [Package]; Package: Shelf Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160578

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [NuStat]

• 00850392006582: N-0404-2
• 00850392006575: N-0404-1
• 00850392006018: NS-0404
• 00850392006155: NuStat 4x4