FDA.reportPublic FDA data

NA

Primary DI
08033695727152
Brand
NA
Company
FIAB SPA
Model
F7255
Catalog number
F7255
Device description
LTC (low temperature cautery) F7255 model is a sterile bipolar battery operated disposable device used for the cauterization of tissues and capillary vessels. F7255 model is equipped with fine tip and reaches a maximum working temperature of 600°C (1100°F). It is mainly used for ophtalmology procedures, but is suitable to be used whenever a quick and precise cauterization is necessary, reducing possible damages to surroundings tissues.
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K083428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083428000F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab Spa2009-09-01HQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033695727159PrimaryGS10
08033695727152Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803369572715918033695727159
08033695727152080336957271528033695727152

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
439770017
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
18033695727166NAF7277F72772020-05-14
18033695727456NAF7244/1F7244/12020-05-14
08033695726414NAF6748RAHAF6748RAHA2023-10-09

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Primary DI, Brand, Company table
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