GUDID 00862992000358

The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.

FORT DEFIANCE INDUSTRIES, LLC

Steam sterilizer

• Primary Device ID: 00862992000358
• NIH Device Record Key: 572eb051-fecc-4a53-ba8b-c164f3e45555
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FRONT-LINE FL135
• Company DUNS: 178610390
• Company Name: FORT DEFIANCE INDUSTRIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com
• Phone: 865-408-0100
• Email: techsupport@fortdefianceind.com

Device Dimensions

• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound
• Length: 31.875 Inch
• Width: 21.5 Inch
• Height: 23.52 Inch
• Weight: 145 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862992000358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213457

FDA Product Code

• FLE: Sterilizer, Steam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-09
• Device Publish Date: 2024-02-01

Devices Manufactured by FORT DEFIANCE INDUSTRIES, LLC

• 00862992000358 - NA: 2024-02-09The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
• 00862992000358 - NA: 2024-02-09 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable med
• 00862992000341 - NA: 2023-08-10 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medi
• 00862992000303 - NA: 2018-07-06 The P2131 Automated Field Sterilizer (AFS) is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of
• 00862992000310 - NA: 2018-07-06 The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of the P2131 Automated Field Sterilizer system. The P2131 is
• 00862992000327 - NA: 2018-07-06 The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Steriliz
• 00862992000334 - NA: 2018-07-06 The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale