ELAN 4

Basic Information

• Brand Name: ELAN 4
• Primary DI: 04046955066766
• Version / Model: MG716R
• Catalog Number: MG716R
• Company Name: AESCULAP, INC.
• Labeler DUNS: 082594540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-19
• Public Version: 2
• Public Version Date: 2022-07-14
• Public Version Status: Update
• Public Device Record Key: df6e37b4-931a-4218-9be7-353e0e1a8160

Device Description

GOULIAN DERMAT.DEPTH GAUGE/GUARD 0.2MM

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: 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
HTJ	GAUGE, DEPTH	Orthopedic	888.4300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33400	Mastoid gauge	A manual surgical instrument designed for introduction into and calibration of the mastoid bone antrum during surgical procedures (e.g., mastoidectomy). It is typically a slender, hand-held, calibrated (e.g., in millimetres) metallic device with an angled blunt distal end (also known as a searcher or seeker). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046955066766	GS1

Customer Contacts

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