FDA.reportPublic FDA data

NA

Primary DI
00862992000358
Brand
NA
Company
FORT DEFIANCE INDUSTRIES, LLC
Model
FRONT-LINE FL135
Device description
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.
Published
2024-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, Steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213457000Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135Fort Defiance Industries, LLC2022-03-02FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862992000358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862992000358008629920003588629920003580862992000358

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height23.52Inch
Length31.875Inch
Weight145Pound
Width21.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-408-0100techsupport@fortdefianceind.com

Regulatory Flags#

DUNS number
178610390
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862992000341NAFRONT-LINE FL1202023-08-02
00862992000303NAP21312016-09-20
00862992000310NAP2131-12016-09-20
00862992000327NAP2131-22016-09-20
00862992000334NAP2131-32016-09-20

Other Devices Sharing Product Codes#

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07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422318BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
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05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-02-16
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05902533549115Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
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07640397421731STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
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07640397421755STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421793STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664303EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
05904165664310EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
05902533548842Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-15
05902533548828Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548835Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
05902533548873Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08
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