FDA.reportPublic FDA data

mocom

Primary DI
08033837931171
Brand
mocom
Company
CEFLA SOCIETA' COOPERATIVA
Model
B Classic-22
Catalog number
M7A760010
Device description
Table top steam sterilizer to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.
Published
2017-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K161848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161848000Family of Steam sterilizers B17 B22 SeriesCefla S.C.2017-02-23FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033837931171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837931171080338379311718033837931171

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal110 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 (704)598-0020service@cefladental.com

Regulatory Flags#

DUNS number
429341410
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033837933021CEFLAVENUS PLUS966010702026-10-13
08033837933045CEFLAVENUS PLUS966010902026-10-13
08033837938583CEFLAVENUS PLUS966010402026-10-13
08033837938606CEFLAVENUS PLUS966010412026-10-13
08033837938644CEFLAVENUS PLUS966011002026-10-13
08033837938682CEFLAVENUS PLUS966011012026-10-13
08033837938699CEFLAVENUS PLUS966010422026-10-13
08033837938705CEFLAVENUS PLUS966010432026-10-13
08033837938712CEFLAVENUS PLUS966010302026-10-13
08033837938729CEFLAVENUS PLUS966011022026-10-13
08033837938736CEFLAVENUS PLUS966010322026-10-13
08033837938743CEFLAVENUS PLUS966010332026-10-13
08033837938835no brandNeowise7XPD2026-05-11
08033837935889Anthosi-MMs FLUO955206732026-04-16
08033837935896Anthosi-MMr L FLUO955206722026-04-16
08033837935902Stern Weberi-XS4 FLUO955206752026-04-16
08033837935919Stern Weberi-XR3 L FLUO955206742026-04-16
08033837935926Castelliniimplantor LED FLUO955206772026-04-16
08033837935933Castellinihandy power LED FLUO955206762026-04-16
08033837938316CEFLAAPEX LOCATOR760002012026-03-31

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