GUDID 00862992000341

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 Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer Steam sterilizer
Primary Device ID00862992000341
NIH Device Record Key2b0721c2-01f9-4c2f-b319-bc2b4cf4fbfd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFRONT-LINE FL120
Company DUNS178610390
Company NameFORT DEFIANCE INDUSTRIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com
Phone865-408-0100
Emailtechsupport@fortdefianceind.com

Device Dimensions

Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound
Length31.3125 Inch
Width19.875 Inch
Height21.625 Inch
Weight139 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS100862992000341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLESterilizer, Steam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-10
Device Publish Date2023-08-02

Devices Manufactured by FORT DEFIANCE INDUSTRIES, LLC

00862992000358 - NA2024-02-09 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable med
00862992000341 - NA2023-08-10The 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.
00862992000341 - NA2023-08-10 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medi
00862992000303 - NA2018-07-06 The P2131 Automated Field Sterilizer (AFS) is an automated, pre- and post-vacuum steam sterilizer designed for sterilization of
00862992000310 - NA2018-07-06 The P2131-1 Sterilizer Main Unit (SMU) is the sterilizer component of the P2131 Automated Field Sterilizer system. The P2131 is
00862992000327 - NA2018-07-06 The P2131-2 Water Recovery System (WRS) is the water recycling and vacuum source component of the P2131 Automated Field Steriliz
00862992000334 - NA2018-07-06 The P2131-3 Sterilizer Water Softener (SWS) is the component that filters and de-mineralizes the incoming water to prevent scale
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