NuStat XR

GUDID 10850392006169

BEEKEN BIOMEDICAL LLC

Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated Wound dressing kit, non-medicated

• Primary Device ID: 10850392006169
• NIH Device Record Key: d1c20fc1-640e-455a-8c1a-5771da1f52a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuStat XR
• Version Model Number: XR-0408
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392006162 [Primary]
GS1	10850392006169 [Package]; Contains: 00850392006162; Package: Shelf Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183190

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2024-02-28
• Device Publish Date: 2024-02-20

Devices Manufactured by BEEKEN BIOMEDICAL LLC

• 10850392006169 - NuStat XR: 2024-02-28
• 10850392006169 - NuStat XR: 2024-02-28
• 00850392006100 - NuStat Flex: 2023-05-12 NuStat Flex hemostatic wound dressing
• 00850392006155 - NuStat: 2023-03-09 NuStat 4x4
• 00850392006018 - NuStat: 2022-11-28
• 00850392006179 - NuStat Trauma Pad XR: 2021-01-18
• 00850392006223 - NuStat Flex XR: 2021-01-18
• 00850392006230 - NuStat Flex XR: 2021-01-18
• 00850392006247 - NuStat Flex XR: 2021-01-18