FDA.report

Salinetrodeflex Bipolar RF Electrode

Primary DI
00851545007449
Brand
Salinetrodeflex Bipolar RF Electrode
Company
PROSURG INC
Model
26 B 73 S
Device description
SALINETRODFLEX FLEXIBLE 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

Related Records

Product Codes

CodeName
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications

CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10851545007446PackageGS15In Commercial Distribution
00851545007449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154500744610851545007446
00851545007449008515450074498515450074490851545007449

GMDN Terms

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

TypeValueUnit
Catheter Gauge2.6French
Length73Centimeter

Sterilization Methods

Method

Contacts

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

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10851545007712ProsurgNAR40NAR402020-05-12
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10851545007811ProsurgNAN23NAN232020-05-12
10851545007187ProsurgBB-24SSBB-24SS2020-05-21
10851545007309ProsurgSCL-24SSSCL-24SS2020-05-12
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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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