Pink Achieve™ BCA1211/B

GUDID 20884450444287

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450444287
• NIH Device Record Key: 55c8a6a2-d860-4dbe-b6d8-94ba4b77f6cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pink Achieve™
• Version Model Number: 10884450444280
• Catalog Number: BCA1211/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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450444283 [Unit of Use]
GS1	10884450444280 [Primary]
GS1	20884450444287 [Package]; Contains: 10884450444280; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141552

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

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: 2020-07-10
• Device Publish Date: 2020-07-02

On-Brand Devices [Pink Achieve™]

• 20884450444317: 10884450444310
• 20884450444287: 10884450444280
• 20884450444256: 10884450444259
• 20884450444263: 10884450444266
• 20884450444201: 10884450444204
• 20884450444218: 10884450444211
• 20884450444294: 10884450444297
• 20884450444232: 10884450444235