FDA.reportPublic FDA data

BRAVO G4 Chamber Autoclave

Primary DI
07640397422073
Brand
BRAVO G4 Chamber Autoclave
Company
Dent4You AG
Model
7A620010
Catalog number
7A620010
Device description
Dynamic-air-removal (pre-vacuum) table-top steam sterilizer, 17L, 120V
Published
2025-07-22
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
K210326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210326000Bravo G4 Chamber AutoclaveScican , Ltd.2021-07-01FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540196002479PreviousGS10
07640397422073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540196002479075401960024797540196002479
07640397422073076403974220737640397422073

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
480152811
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397422189HYDRIM 112W G4+ Instrument WasherG4-W10001G4-W100012026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherG4-W10001-LG4-W10001-L2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherG4-W10001-RG4-W10001-R2026-02-11
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2025-07-22
07640397421885HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2025-01-15
07640397421908HYDRIM C61W G4 Instrument WasherC61W-D01-RC61W-D01-R2025-01-15
07640397421915HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2025-01-15
07640397421922HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2025-01-15
07640397421939HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2025-01-15
07640397421960HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42025-01-15
07630243601202ParaCore588658862026-07-07
07630243601219ParaCore588758872026-07-07
07630243601226ParaCore60011391600113912026-07-07
07630243601301ParaCore60011392600113922026-07-07

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Primary DI, Brand, Company table
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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
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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
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
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