AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04046963186531
• Version / Model: FH604SU
• Catalog Number: FH604SU
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-01-16
• Public Version Status: Update
• Public Device Record Key: 70c8785d-e1a5-4e6c-8813-0227942f76d5

Device Description

MINOP DISPOSABLE INTRODUCER 19FR

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: 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
GWG	ENDOSCOPE, NEUROLOGICAL	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61440	Intracerebral trocar blade	A sterile, hand-held, manual surgical instrument with a sharp, needle-like point intended to be used in conjunction with an intracerebral catheter (e.g., ventricular catheter) to puncture tissue and create a channel to access the brain (e.g., cerebral ventricles, cystic tumours) typically for cerebrospinal fluid (CSF) drainage or infusion of materials (e.g., chemotherapeutic agents). It is inserted within the lumen of the intracerebral catheter prior to catheter insertion; the catheter 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	04046963186531	GS1
Unit of Use	04046963178864	GS1

Customer Contacts

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