TELEFLEX

Basic Information

• Brand Name: TELEFLEX
• Primary DI: 14026704921772
• Version / Model: IPN928804
• Catalog Number: SPU01
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-13
• Public Version: 2
• Public Version Date: 2026-02-02
• Public Version Status: Update
• Public Device Record Key: 4b4eea21-6396-49b0-8f85-a6e5a068bcab

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDW	Staple, implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58483	Endoscopic motorized cutting stapler, single-use	A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses; it may also be used during open surgery. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor in the handle. This device is typically loaded with staples and may be pistol-like in design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14026704921772	GS1
Direct Marking	24026704921779	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210278	000