FDA.reportPublic FDA data

Getinge GSS610N Series Steam Sterilizer

Primary DI
04053275000066
Brand
Getinge GSS610N Series Steam Sterilizer
Company
MAQUET GmbH
Model
610N10
Published
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K201927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201927000Getinge GSS610N Series Steam SterilizerMaquet GmbH2021-03-01FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04053275000066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04053275000066040532750000664053275000066

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315435859
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04053275000011GETINGE6710GSS67N Model 67102019-02-06
04053275000028GETINGE 6713GSS67N Model 67132019-02-06
04053275000035GETINGE6717GSS67N Model 67172019-02-06
04046768146600Traction Adapter100372AC2025-11-30
04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768000094Connection bracket100208002022-09-22
04046768000124Connector100258002022-09-22
04046768000421Cross-bar attachment100523002022-09-22
04046768000452Support arm100558002022-09-22
04046768001510Head rest adapter100207A02022-09-22
04046768001657Fixture100265A02022-09-22
04046768001688Horseshoe head rest100272A02022-09-22
04046768001695Flat head rest100273A02022-09-22
04046768001701Motorised head rest adjustment100274A02022-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05902533549597Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-10-16
00724995364168AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364175AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364182AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364199AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364205AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364212AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364236AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364267AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364274AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364281AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364298AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364304AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364311AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364328AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364335AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364342AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364359AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364366AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364373AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364380AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364397AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364557AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995368562AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12