EUROPCLIP Applier

Basic Information

• Brand Name: EUROPCLIP Applier
• Primary DI: 04250302286008
• Version / Model: 13-1613-106AS
• Company Name: Ackermann Instrumente GmbH
• Labeler DUNS: 315121009
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-10
• Public Version: 1
• Public Version Date: 2022-02-18
• Public Version Status: New
• Public Device Record Key: 9b59b271-2efb-4dda-b936-18ca0ae7dd43

Device Description

Clip Applicator for Large Clips, Rotable, Double Action, 330 mm, Ø12,5 mm

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: Yes
• 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
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65058	Endoscopic surgical ligation clip applier, reusable	A hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250302286008	GS1

Customer Contacts

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