TEMNO Evolution® TT206/B

GUDID 20884450443648

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450443648
• NIH Device Record Key: 1301b32f-7f87-4402-b038-749fb889656e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMNO Evolution®
• Version Model Number: 10884450443641
• Catalog Number: TT206/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	00884450443644 [Unit of Use]
GS1	10884450443641 [Primary]
GS1	20884450443648 [Package]; Contains: 10884450443641; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024120

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: 2020-09-22
• Device Publish Date: 2020-09-14

On-Brand Devices [TEMNO Evolution®]

• 20884450443365: 10884450443368
• 20884450443235: 10884450443238
• 20884450443402: 10884450443405
• 20884450443600: 10884450443603
• 20884450443242: 10884450443245
• 20884450443396: 10884450443399
• 20884450443419: 10884450443412
• 20884450443563: 10884450443566
• 20884450443389: 10884450443382
• 20884450443426: 10884450443429
• 20884450443358: 10884450443351
• 20884450443464: 10884450443467
• 20884450443556: 10884450443559
• 20884450443648: 10884450443641
• 20884450443372: 10884450443375
• 20884450443495: 10884450443498
• 20884450443631: 10884450443634
• 20884450443587: 10884450443580
• 20884450443518: 10884450443511
• 20884450443570: 10884450443573
• 20884450443624: 10884450443627
• 20884450443617: 10884450443610
• 20884450443549: 10884450443542
• 20884450443471: 10884450443474
• 20884450443525: 10884450443528
• 20884450443341: 10884450443344
• 20884450443594: 10884450443597
• 20884450443501: B