AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653209408
• Version / Model: ER871R
• Catalog Number: ER871R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 2
• Public Version Date: 2021-05-28
• Public Version Status: Update
• Public Device Record Key: ad6fd5ac-7d80-469a-84e2-b5c190f045df
• Distribution End Date: 2021-04-23

Device Description

LEECH-WILKINSON Uterine Irrigation Cannula, 10 1/2", (265 mm), diam. 10 mm - 25 mm, small, non-sterile, reusable

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
FGY	CANNULA, INJECTION	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11265	Urethral dilator, reusable	A slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653209408	GS1

Customer Contacts

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