Adjustable Coaxial TEMNO™ A.C.T. ACT1811/B

GUDID 20884450444027

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450444027
• NIH Device Record Key: 29b08fcb-18e4-4c83-8461-7e3d164ebd3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adjustable Coaxial TEMNO™ A.C.T.
• Version Model Number: 10884450444020
• Catalog Number: ACT1811/B
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 5
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450444023 [Unit of Use]
GS1	10884450444020 [Primary]
GS1	20884450444027 [Package]; Contains: 10884450444020; Package: [18 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902319

FDA Product Code

• FCG: Biopsy needle

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: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Adjustable Coaxial TEMNO™ A.C.T.]

• 20884450444027: 10884450444020
• 20884450444065: 10884450444068
• 20884450444034: 10884450444037
• 20884450444058: 10884450444051
• 20884450444089: 10884450444082
• 20884450444102: 10884450444105
• 20884450444072: 10884450444075
• 20884450444041: 10884450444044
• 20884450444010: 10884450444013