FDA.reportPublic FDA data

Prosurg

Primary DI
10851545007705
Brand
Prosurg
Company
PROSURG INC
Model
SCC
Catalog number
SCC
Device description
Salinetrode Bipolar Cable
Published
2020-05-21
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

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
K962593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962593000ELECTROSURGICAL PROBES & DEVICESXimed/Prosure/Injectx1996-11-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851545007705PackageGS11In Commercial Distribution
00851545007708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085154500770510851545007705
00851545007708008515450077088515450077080851545007708

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 inert gas-enhanced electrosurgery.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
4084835474Ashvin@prosurg.com

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
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851545007715ProsurgNAR40NAR402020-05-12
00851545007722ProsurgNAN18NAN182020-05-12
00851545007814ProsurgNAN23NAN232020-05-12
10851545007712ProsurgNAR40NAR402020-05-12
10851545007729ProsurgNAN18NAN182020-05-12
10851545007811ProsurgNAN23NAN232020-05-12
08714729516750Signature Series M00688025702016-09-23
08714729520375Signature Series M00688020702016-09-23
08714729520382Signature Series M00688021502016-09-23
08714729520405Signature Series M00688021702016-09-23
08714729520412Signature Series M00688022502016-09-23
08714729520429Signature Series M00688022602016-09-23
08714729520436Signature Series M00688022702016-09-23
08714729520443Signature Series M00688023502016-09-23
08714729520450Signature Series M00688023602016-09-23
08714729520467Signature Series M00688023702016-09-23
08714729520474Signature Series M00688024502016-09-23
08714729520481Signature Series M00688024602016-09-23
08714729520498Signature seriesM00688024702016-09-23
08714729520504Signature Series M00688025502016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092978ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092985ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092992ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093340ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093449ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093456ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
10884450452360STAR™Merit Medical Systems, Inc.GEI2026-07-28