Achieve® CA1415/B

GUDID 20884450444348

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450444348
• NIH Device Record Key: 32e854d7-57e7-4332-ac2a-2fa799bc1e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Achieve®
• Version Model Number: 10884450444341
• Catalog Number: CA1415/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	00884450444344 [Unit of Use]
GS1	10884450444341 [Primary]
GS1	20884450444348 [Package]; Contains: 10884450444341; 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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [Achieve®]

• 20884450443730: 10884450443733
• 20884450443785: 10884450443788
• 20884450444423: 10884450444426
• 20884450444430: 10884450444433
• 20884450444324: 10884450444327
• 20884450443969: 10884450443962
• 20884450444485: 10884450444488
• 20884450443709: 10884450443702
• 20884450444454: 10884450444457
• 20884450444508: 10884450444501
• 20884450443938: 10884450443931
• 20884450444379: 10884450444372
• 20884450443693: 10884450443696
• 20884450443945: 10884450443948
• 20884450444478: 10884450444471
• 20884450444409: 10884450444402
• 20884450444393: 10884450444396
• 20884450444348: 10884450444341
• 20884450443952: 10884450443955
• 20884450443907: 10884450443900
• 20884450443914: 10884450443917
• 20884450444362: 10884450444365
• 20884450443716: 10884450443719
• 20884450443723: 10884450443726
• 20884450443778: 10884450443771
• 20884450443747: 10884450443740
• 20884450443754: 10884450443757
• 20884450443990: 10884450443993
• 20884450444003: 10884450444006
• 20884450444195: 10884450444198
• 20884450443983: 10884450443986
• 20884450443976: 10884450443979
• 20884450443761: 10884450443764