FDA.reportPublic FDA data

NA

Primary DI
18033695727166
Brand
NA
Company
FIAB SPA
Model
F7277
Catalog number
F7277
Device description
HTC (high temperature cautery) F7277model is a sterile bipolar battery operated disposable device for the cauterization of small vessels. The fine tip length 125mm permits the accurate and effective cauterization of very small vessels. Tip reaches a maximum working temperature of 1.200°C (2.200 °F) The cautery is suitable to be used all the times a quick and precise cauterization is necessary even in difficult access sites
Published
2020-05-14
Public version status
Update
Distribution status
Not 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
18033695727166PrimaryGS10
08033695727169Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803369572716618033695727166
08033695727169080336957271698033695727169

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 Humidity25 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 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
28058480756401NAF7244F72442024-09-05
28058480757415NAF7255F72552024-09-05
18033695727142NAF7244F72442020-05-14
18033695727159NAF7255F72552020-05-14
18033695727456NAF7244/1F7244/12020-05-14
08033695726414NAF6748RAHAF6748RAHA2023-10-09
08033003264676NAF6726P/NK33F6726P/NK332024-03-19

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