AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04046964686184
• Version / Model: MA917R
• Catalog Number: MA917R
• Company Name: AESCULAP, INC.
• Labeler DUNS: 082594540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-25
• Public Version: 2
• Public Version Date: 2021-10-25
• Public Version Status: Update
• Public Device Record Key: 6fd6730e-27bb-4bb5-994f-418c6d7e2eb5

Device Description

RUEDEMANN LACRIMAL DILATOR 12MM 70MM

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
HNW	Dilator, lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35010	Lacrimal dilator, reusable	A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964686184	GS1

Customer Contacts

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