NuStat

GUDID 00850392006018

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

• Primary Device ID: 00850392006018
• NIH Device Record Key: 9f34c20e-fa47-42d4-bc98-f069e2b4cc23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuStat
• Version Model Number: NS-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: true
• 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	00850392006001 [Primary]
GS1	00850392006018 [Package]; Contains: 00850392006001; Package: Shelf Pack [10 Units]; In Commercial Distribution
GS1	00850392006056 [Package]; Contains: 00850392006001; Package: Shelf Pack [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160578

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2022-09-16

On-Brand Devices [NuStat ]

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