TEMNO® CT1611/B

GUDID 20884450444140

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450444140
• NIH Device Record Key: 9cd33a5b-f3ef-4b77-9c2c-e4b87aef9432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMNO®
• Version Model Number: 10884450444143
• Catalog Number: CT1611/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	00884450444146 [Unit of Use]
GS1	10884450444143 [Primary]
GS1	20884450444140 [Package]; Contains: 10884450444143; 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: 2020-07-30
• Device Publish Date: 2020-07-22

On-Brand Devices [TEMNO®]

• 20884450443211: 10884450443214
• 20884450444607: 10884450444600
• 20884450444270: 10884450444273
• 20884450444249: 10884450444242
• 20884450444188: 10884450444181
• 20884450444157: 10884450444150
• 20884450444119: 10884450444112
• 20884450444171: 10884450444174
• 20884450444560: 10884450444563
• 20884450444140: 10884450444143
• 20884450444553: 10884450444556
• 20884450444225: 10884450444228
• 20884450444355: 10884450444358
• 20884450444584: 10884450444587
• 20884450443198: 10884450443191
• 20884450444669: 10884450444662
• 20884450443136: 10884450443139
• 20884450444591: 10884450444594
• 20884450444539: 10884450444532
• 20884450444164: 10884450444167
• 20884450444652: 10884450444655
• 20884450444461: 10884450444464
• 20884450443174: 10884450443177
• 20884450444386: 10884450444389
• 20884450444447: 10884450444440
• 20884450444126: 10884450444129
• 20884450444416: 10884450444419
• 20884450444522: 10884450444525
• 20884450444492: 10884450444495
• 20884450444621: 10884450444624
• 20884450444546: 10884450444549
• 20884450444515: 10884450444518
• 20884450444300: 10884450444303
• 20884450444577: 10884450444570
• 20884450444331: 10884450444334
• 20884450444133: 10884450444136
• 20884450444706: 10884450444709
• 20884450444645: 10884450444648
• 20884450444676: 10884450444679