FDA.reportPublic FDA data

NA

Primary DI
28058480756401
Brand
NA
Company
FIAB SPA
Model
F7244
Catalog number
F7244
Device description
HTC (high temperature cautery) F7244 model is a sterile bipolar battery operated disposable device used for the cauterization of tissues and capillary vessels. F7244 model is equipped with fine tip that permits the cauterization of very small vessels and is suitable to be used all the times a quick and precise cauterization is necessary. F7244 reaches a maximum working temperature of 1.200°C (2.200 °F). The cautery allows you to remove the batteries at the end of its use
Published
2024-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100333000FIAB SPA, MODELS F7244, F7233, F7234, F7277Fiab Spa2010-06-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28058480756401PrimaryGS10
08058480756407Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2805848075640128058480756401
08058480756407080584807564078058480756407

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, battery-poweredA battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+390558497943quality@fiab.it

Regulatory Flags#

DUNS number
439770017
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054242441765NAU7951U79512020-04-12
08054242441772NAU7952U79522020-04-12
08054242441789NAU7955U79552020-04-12
08054242441796NAU7961U79612020-04-12
08054242441802NAU7750U77502020-04-12
08054242441819NAU7751U77512020-04-12
08054242441826NAU7752U77522020-04-12
08054242441833NAU7755U77552020-04-12
08054242441840NAU7761U77612020-04-12
08054242444933NAU7959U79592020-04-12
08054242441758NAU7950U79502020-04-12
08054751932464NAF7266F72662025-07-27
08033695726360NAF6738RAHAF6738RAHA2024-09-16
28058480757415NAF7255F72552024-09-05
18033695727142NAF7244F72442020-05-14
18033695727159NAF7255F72552020-05-14
18033695727166NAF7277F72772020-05-14
18033695727456NAF7244/1F7244/12020-05-14
08033695726414NAF6748RAHAF6748RAHA2023-10-09
08033003264676NAF6726P/NK33F6726P/NK332024-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
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07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10