AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653019694
• Version / Model: BA705
• Catalog Number: BA705
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-03-09
• Public Version: 1
• Public Version Date: 2022-03-17
• Public Version Status: New
• Public Device Record Key: f89b5b69-ff89-4a1d-9ef9-f495de097dc3
• Distribution End Date: 2022-03-09

Device Description

NIB FOR ECKHOFF PEN ONLY

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: Yes
• 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
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32313	Skin marking pen, reusable	A dedicated pen (typically a felt-tip pen) intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04038653338283	GS1
Primary	04038653019694	GS1

Customer Contacts

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