FDA.reportPublic FDA data

Salinetrodeflex Bipolar RF Electrode

Primary DI
00851545007456
Brand
Salinetrodeflex Bipolar RF Electrode
Company
PROSURG INC
Model
26 B 100 S
Device description
SALINETRODEFLEX BIPOLAR RF ELECTRODE
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851545007453PackageGS15In Commercial Distribution
00851545007456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154500745310851545007453
00851545007456008515450074568515450074560851545007456

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge2.6French
Length100Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408 945 4044Prosurg_qa@sbcglobal.net

Regulatory Flags#

DUNS number
188684609
Device count
1
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
10851545007712ProsurgNAR40NAR402020-05-12
10851545007729ProsurgNAN18NAN182020-05-12
10851545007811ProsurgNAN23NAN232020-05-12
10851545007187ProsurgBB-24SSBB-24SS2020-05-21
10851545007309ProsurgSCL-24SSSCL-24SS2020-05-12
10851545007330ProsurgSCL-24OSCL-24O2020-05-12
10851545007354ProsurgSCL-24WNSCL-24WN2020-05-12
10851545007422Prosurg5B40S5B40S2020-05-21
10851545007439Prosurg5B73S5B73S2020-05-21
10851545007705ProsurgSCCSCC2020-05-21
10851545007743ProsurgCL-24SSCL-24SS2020-05-21
10851545007798ProsurgSCBSCB2020-05-12
10851545007828ProsurgBL-24SBL-24S2020-05-21
08714729516767Signature Series M00688025702016-09-23
08714729520351Signature Series M00688020502016-09-23
08714729520368Signature Series M00688020602016-09-23
08714729160465Signature Series M00688020702016-09-23
08714729160502Signature Series M00688021502016-09-23
08714729520399Signature Series M00688021602016-09-23
08714729160526Signature Series M00688021702016-09-23

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Primary DI, Brand, Company table
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