NuStat Trauma Pad XR

GUDID 00850392006599

BEEKEN BIOMEDICAL LLC

Wound dressing kit, non-medicated, sterile

• Primary Device ID: 00850392006599
• NIH Device Record Key: 098a85e5-5aea-44ba-97df-3e7096e1f4a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuStat Trauma Pad XR
• Version Model Number: XR-0404
• 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	00850392006599 [Primary]
GS1	10850392006596 [Package]; Package: Shelf Pack [50 Units]; In Commercial Distribution
GS1	20850392006593 [Package]; 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: 2021-01-18
• Device Publish Date: 2021-01-08

On-Brand Devices [NuStat Trauma Pad XR]

• 00850392006704: XR-0448
• 00850392006605: XR-0404-5
• 00850392006599: XR-0404
• 00850392006544: XR-0812-5
• 00850392006179: XR-0812