ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 00801902001900
• Version / Model: IPN000142
• Catalog Number: CL-07724
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2020-03-26
• Public Version Status: Update
• Public Device Record Key: d295ac2a-5165-4201-81a4-3430e2b05aa0

Device Description

Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
DQY	Catheter, percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46505	Surgical instrument guard, single-use, sterile	A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30801902001901	GS1	Case	5	In Commercial Distribution
Primary	00801902001900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K862056	000