N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00367979855001
• Version / Model: 9 Gauge Disposable Trocar with Blunt Pusher (50134)
• Company Name: ENDO PHARMACEUTICALS INC.
• Labeler DUNS: 178074951
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-24
• Public Version: 1
• Public Version Date: 2021-03-04
• Public Version Status: New
• Public Device Record Key: 68ac9e8e-e36c-4966-8b62-9586e39e24b6

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63148	Pellet implantation cannula	A sterile, rigid tube intended for subcutaneous delivery of an implantable drug pellet. The cannula is typically designed with a proximal well/side-hole for pellet loading, and typically includes a trocar blade to assist cannula introduction and a push rod to drive the pellet down the cannula; the implant is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00367979855001	GS1