TEMNO®

Basic Information

• Brand Name: TEMNO®
• Primary DI: 10884450444686
• Version / Model: 10884450444686
• Catalog Number: T226/B
• Company Name: Merit Medical Systems, Inc.
• Labeler DUNS: 184763290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-01-18
• Public Version: 1
• Public Version Date: 2023-01-26
• Public Version Status: New
• Public Device Record Key: 216f35c7-1afe-4c62-bbb3-2f9cd96f7526

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FCG	Biopsy needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450444683	GS1		18	In Commercial Distribution
Primary	10884450444686	GS1
Unit of Use	00884450444689	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Biopsy Device Length (cm)-6.0 cm
Device Size Text, specify			Biopsy Device Gauge-22G