FMS

Basic Information

• Brand Name: FMS
• Primary DI: 10886705000388
• Version / Model: 287345
• Catalog Number: 287345
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 5
• Public Version Date: 2023-05-04
• Public Version Status: Update
• Public Device Record Key: 9c1185c9-7ee9-49f6-a41e-3bc57a8449b8

Device Description

FMS Mini Full Radius Cutter Shaver Blades 3.5mm

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: No
• 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
HRX	ARTHROSCOPE	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41499	Arthroscopic shaver system blade, single-use	A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705000385	GS1	PACKAGE	5	In Commercial Distribution
Primary	10886705000388	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K954465	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 41 – 120 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Storage Environment Temperature
• Temperature Range: 41 – 120 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 5 – 49 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 49 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Pallet 2 Stacked