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 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 ID00862992000358
NIH Device Record Key572eb051-fecc-4a53-ba8b-c164f3e45555
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFRONT-LINE FL135
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

Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound
Length31.875 Inch
Width21.5 Inch
Height23.52 Inch
Weight145 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS100862992000358 [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 Date2024-02-09
Device Publish Date2024-02-01

Devices Manufactured by FORT DEFIANCE INDUSTRIES, LLC

00862992000358 - NA2024-02-09The 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 - NA2024-02-09 The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture- stable med
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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