FDA.reportPublic FDA data

mocom

Primary DI
08033837931140
Brand
mocom
Company
CEFLA SOCIETA' COOPERATIVA
Model
B Classic-17
Catalog number
M7A720010
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
08033837931140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837931140080338379311408033837931140

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
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage 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
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
08033837932796Castellinihandy POWER955206662022-06-02
08033837930389Anthosi-MMs955206622022-06-01
08033837930402Castelliniimplantor LED955206682022-06-01
08033837930723Stern Weberi-XR3955206632022-06-01
08033837930730Stern Weberi-XR3 L955206642022-06-01
08033837930747Stern Weberi-XS4955206652022-06-01
08033837932789Castellinihandy POWER LED955206672022-06-01
08033837935025Anthosi-MMr955206602022-06-01
08033837935032Anthosi-MMr L955206612022-06-01
08033837934981myrayProXIma X6 (2D)70EA00002026-03-13
08033837935001myrayProXIma X6 (3D)70EB00002026-03-13
08033837936091NewTomNewTom VG-One (2D)70ED00002026-03-13

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