RUSCH

Basic Information

• Brand Name: RUSCH
• Primary DI: 14026704664310
• Version / Model: IPN039028
• Catalog Number: 1400
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-18
• Public Version: 3
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: ec818cdb-167a-4f14-a58a-e7146492e408

Device Description

Encapsulon Epidural Needle - Tuohy Style

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58293	Epidural needle, non-threaded	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704664317	GS1	Box	10	In Commercial Distribution
Primary	14026704664310	GS1
Package	34026704664314	GS1	Case	10	In Commercial Distribution
Previous	04026704541799	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K850111	000