FDA.reportPublic FDA data

Amsco Eagle

Primary DI
00724995152017
Brand
Amsco Eagle
Company
Steris Mexico, S. de R.L. de C.V.
Model
3017
Catalog number
FF85
Device description
The Amsco Eagle EO Sterilizer, Tabletop 100% ethylene oxide (EO) gas sterilizer/aerator provides effective low-temperature sterilization of heat-sensitive items.
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLFSterilizer, ethylene-oxide gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLFSterilizer, Ethylene-Oxide GasGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931872000THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZERAmerican Sterilizer Co.1994-02-07FLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995152017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152017007249951520177249951520170724995152017

GMDN Terms#

Term, Definition table
TermDefinition
Ethylene oxide sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using ethylene oxide (ETO) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris and packed in gas permeable wraps; a means to introduce the gas into the chamber; and controls to chose one of the sterilization cycles. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
813116209
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995364168AMSCOAMSCO 700 Steam SterilizerEJ11202210012026-10-08
00724995364175AMSCOAMSCO 700 Steam SterilizerEJ11201400012026-10-08
00724995364182AMSCOAMSCO 700 Steam SterilizerEJ11202410012026-10-08
00724995364199AMSCOAMSCO 700 Steam SterilizerEJ11201410012026-10-08
00724995364205AMSCOAMSCO 700 Steam SterilizerEJ12201100012026-10-08
00724995364212AMSCOAMSCO 700 Steam SterilizerEJ12201400012026-10-08
00724995364229AMSCOAMSCO 700 Steam SterilizerEJ12202410012026-10-08
00724995364236AMSCOAMSCO 700 Steam SterilizerEJ12201410012026-10-08
00724995364243AMSCOAMSCO 700 Steam SterilizerEJ12213410012026-10-08
00724995364250AMSCOAMSCO 700 Steam SterilizerEJ13201100012026-10-08
00724995364267AMSCOAMSCO 700 Steam SterilizerEJ13201400012026-10-08
00724995364274AMSCOAMSCO 700 Steam SterilizerEJ13213400012026-10-08
00724995364281AMSCOAMSCO 700 Steam SterilizerEJ112022100112026-10-08
00724995364298AMSCOAMSCO 700 Steam SterilizerEJ112014000112026-10-08
00724995364304AMSCOAMSCO 700 Steam SterilizerEJ112024100112026-10-08
00724995364311AMSCOAMSCO 700 Steam SterilizerEJ112014100112026-10-08
00724995364328AMSCOAMSCO 700 Steam SterilizerEJ122011000112026-10-08
00724995364335AMSCOAMSCO 700 Steam SterilizerEJ122014000112026-10-08
00724995364342AMSCOAMSCO 700 Steam SterilizerEJ122024100112026-10-08
00724995364359AMSCOAMSCO 700 Steam SterilizerEJ122014100112026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060485030706AN4000.60 EOGas 4 Ethylene Oxide Gas Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030713AN4000.61 EOGas 4 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
05060485030744AN4000.67 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 230VANDERSEN STERILIZERS INC.FLF2023-08-31
10705037067244SEALSURE™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2021-02-11
007073877870113M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877870283M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875613M™ Steri-Vac™3M COMPANYFLF2020-10-22
007073877875783M™ Steri-Vac™3M COMPANYFLF2020-10-22
05060485030607Anprolene AN75 Ethylene Oxide SterilizerANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030614Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030621Anprolene AN75 Ethylene Oxide Sterilizer, 115VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030638Anprolene AN75 Ethylene Oxide Gas Sterilizer, 230VANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030669Anprolene AN75 Refill Kit, 14 UnitsANDERSEN STERILIZERS INC.FLF2020-08-14
05060485030164 EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030331AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030393EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030409EOGas 4 Ethylene Oxide Gas SterilizerANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030416EOGas 4 Sterilization BagANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030430AN1071 HumidichipANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030447EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
05060485030454EOGas 4 Refill KitANDERSEN STERILIZERS INC.FLF2018-09-01
10705037014583STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014651SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
20705037014658SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
10705037014460SterradADVANCED STERILIZATION PRODUCTS SERVICES INC.FLF2016-09-24
50707387767247Steri-Vac™3M COMPANYFLF2016-09-24
50707387767254Steri-Vac™3M COMPANYFLF2016-09-24
50707387767261Steri-Vac™3M COMPANYFLF2016-09-24
50707387767278Steri-Vac™3M COMPANYFLF2016-09-24
50724995010336EnvirosystemsSTERIS CORPORATIONFLF2016-09-08