Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C

Basic Information

• Brand Name: Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
• Primary DI: 04251783104133
• Version / Model: 04366300
• Company Name: Assamed GmbH - Medizinbedarf
• Labeler DUNS: 319354346
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-30
• Public Version: 1
• Public Version Date: 2023-04-07
• Public Version Status: New
• Public Device Record Key: 58da3bf6-59d5-44c5-8937-d5b423dbe254

Device Description

Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBX	Catheter, Irrigation	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46102	Surgical irrigation tubing set, single-use	A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14251783104130	GS1		4	In Commercial Distribution
Primary	04251783104133	GS1
Package	24251783104137	GS1		104	In Commercial Distribution

Customer Contacts

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