Temno

Basic Information

• Brand Name: Temno
• Primary DI: 10885403089909
• Version / Model: PP1510A
• Catalog Number: PP1510A
• Company Name: CAREFUSION 2200, INC
• Labeler DUNS: 832696038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-18
• Public Version: 2
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 62f495e0-556c-46ea-a9e6-5deea1fa492b
• Distribution End Date: 2019-11-30

Device Description

Temno Coaxial Introducer Needle 15G X10CM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
GDF	GUIDE, NEEDLE, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885403089907	GS1	Case	10	Not in Commercial Distribution	2019-11-30
Primary	10885403089909	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]