FDA.reportPublic FDA data

SHINVA

Primary DI
06970614967416
Brand
SHINVA
Company
Shinva Medical Instrument Co., Ltd.
Model
MOST-T
Published
2024-10-31
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
K220102000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220102000MOST-T AutoclaveShinva Medical Instrument Co., Ltd.2022-10-12FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970614967416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970614967416069706149674166970614967416

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
653915710
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12
06972615108058icanclaveNingbo Ican Machines Co., Ltd.FLE2026-04-26
07640397422271BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422288BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422295BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422301BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422318BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07640397422325BRAVO G4 Chamber AutoclaveDent4You AGFLE2026-04-20
07629999282957Enbio-Autoclave Control FirmwareEnbio Group AGFLE2026-03-02
07629999900769Enbio PRO (ver. USA/CAN)Enbio Group AGFLE2026-03-02
05902533549214Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-02-16
00860014827310Lucas LifecareLucas Lifecare, LLCFLE2026-01-28
05902533549115Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
05902533549122Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-01-16
07640397421731STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
07640397421748STATCLAVE G4 Chamber AutoclaveDent4You AGFLE2026-01-06
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
05902533549023Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2025-08-08