FMS

Basic Information

• Brand Name: FMS
• Primary DI: 10886705016334
• Version / Model: 281580
• Catalog Number: 281580
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 6
• Public Version Date: 2025-03-18
• Public Version Status: Update
• Public Device Record Key: ece83739-e1ec-47a2-be78-65996c47d650

Device Description

FMS Fluid Management System 4.5mm FMS Outflow Cannula

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: No
• 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
HNX	Depressor, orbital	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58752	Arthroscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705016331	GS1	PACKAGE	20	In Commercial Distribution
Primary	10886705016334	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 50 – 95 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Pallet 2 Stacked