FDA.reportPublic FDA data

ESI

Primary DI
B3964500180
Brand
ESI
Company
FTT MEDICAL, INC.
Model
45-0018
Device description
DISPOSABLE SNARE WIRES, SOFT WIRE, ONE DOZEN.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HAMApparatus, Electrosurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAMApparatus, ElectrosurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3964500180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rigid polypectomy snare, single-useA sterile, rigid device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a rigid insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002212793
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B39615001700ESI15-001702016-09-16
B3961501500ESI15-01502016-09-16
B3961501520ESI15-01522016-09-16
B3961501540ESI15-01542016-09-16
B3961501580ESI15-01582016-09-16
B3961501590ESI15-01592016-09-16
B3961501710ESI15-01712016-09-16
B3961501720ESI15-01722016-09-16
B396150172O0ESI15-0172-O2016-09-16
B3961501730ESI15-01732016-09-16
B3961501740ESI15-01742016-09-16
B3961501750ESI15-01752016-09-16
B3961501800ESI15-01802016-09-16
B3961501820ESI15-01822016-09-16
B3961501840ESI15-01842016-09-16
B3961501900ESI15-01902016-09-16
B3961501920ESI15-01922016-09-16
B3961501940ESI15-01942016-09-16
B3961501980ESI15-01982016-09-16
B3961502700ESI15-02702016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019117552KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117569KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117576KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117559KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117566KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117573KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00653405002102CONMEDConmed CorporationHAM2023-11-30
20653405002106CONMEDConmed CorporationHAM2023-11-30
20653405036019ABCConmed CorporationHAM2023-10-11
14026704662118PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
34026704662112PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
19555240400854ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240401141ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400946ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400748ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
14026704662125WECKTELEFLEX INCORPORATEDHAM2019-05-08
24026704662122WECKTELEFLEX INCORPORATEDHAM2019-05-08
20888937014413LEEP Disposable Universal ElectrodesCoopersurgical, Inc.HAM2016-10-05
24026704599879WECKTELEFLEX INCORPORATEDHAM2016-09-30
04026704599875WeckTELEFLEX INCORPORATEDHAM2016-09-30
10653405002475ABCConmed CorporationHAM2016-09-24
10653405002604ABCConmed CorporationHAM2016-09-24
30653405036016ABCConmed CorporationHAM2016-09-24
30653405002103CONMEDConmed CorporationHAM2016-09-24
20653405002472ABCConmed CorporationHAM2016-09-24
20653405002601ABCConmed CorporationHAM2016-09-24
40653405036013ABCConmed CorporationHAM2016-09-24
B3964500140ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500160ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500200ESIFTT MEDICAL, INC.HAM2016-09-20