AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04046963759391
• Version / Model: EK356R
• Catalog Number: EK356R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-22
• Public Version: 3
• Public Version Date: 2020-07-30
• Public Version Status: Update
• Public Device Record Key: 01eab7b4-e43e-4e22-a06f-6659f11b8651

Device Description

TROCAR PIN CONICAL SHARP 3.5/110MM

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37149	Laparoscopic dilation guide rod	A compact metal rod intended to be used during expansion of a laparoscopic access port (e.g., from 10 to 20 mm) by facilitating: 1) removal of an existing access cannula; and 2) introduction of a dilator/cannula assembly. It is inserted into the existing access cannula, keeping the opening airtight whilst the smaller access cannula is removed; a special dilator assembled with a larger access cannula is fed back over the guide rod. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046963759391	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter (mm) : 3.500 MM
Device Size Text, specify			Working length (mm) : 110.000 MM