FDA.reportPublic FDA data

AEM® Monitor, Loaner

Primary DI
10815288014130
Brand
AEM® Monitor, Loaner
Company
ENCISION, INC.
Model
EM3-ZD
Catalog number
EM3-ZD
Published
2022-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815288014130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081528801413010815288014130

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system monitor/shieldA dedicated unit designed to interface with an electrosurgical system to help detect and manage high frequency leakage of current from active electrodes used in combination with endoscopes or other instruments during endoscopic procedures (especially laparoscopic).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612250175
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815288014239AEM® Burn Protection System CableES6107+ES6107+2025-05-27
10815288014369Alligator Forcep, Ratcheting Handle With Rotation, 45cmEP3080-45RREP3080-45RR2025-03-03
10815288014376Curved Maryland Dissector, 23mm Jaw, Ratcheting Handle With Rotation, 45cmEP3410-45RREP3410-45RR2025-03-03
10815288014314Single Action Needle Holder, Ratcheting Handle, With Rotation, 35cmEP3700RREP3700RR2024-02-07
10815288014345Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cmEP3100RREP3100RR2024-02-07
108152880117955mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With RotationES0540RRES0540RR2017-12-27
10815288013799Fenestrating Grasping Forcep, 35cmEP3280RREP3280RR2017-11-22
10815288013805Allis Forcep, 35cmEP3000RREP3000RR2017-11-22
10815288013812Fenestrated Bowel Grasper, 35cm, 20mm JawEP3690RREP3690RR2017-12-18
10815288013829Traumatic Grasper, 35cmEP3020RREP3020RR2018-02-08
10815288014253Rounded Maryland DissectorES0586ES05862023-06-21
10815288014260Rounded Maryland DissectorES0586-45ES0586-452023-06-21
10815288010712AEM® Disposable Handswitching Handpiece with Rocker SwitchES1300ES13002016-08-31
10815288013324PowerGrip Instrument HandleBP7500BP75002016-08-31
10815288013386PowerGrip Instrument HandleBP7500BP75002016-08-31
10815288013898Bipolar Instrument Handle with LockBP7200LBP7200L2018-09-10
10815288010231AEM® HandleES8000ES80002016-08-31
10815288010248AEM® HandleES8000LES8000L2016-08-31
10815288010255AEM® Handle, HoodedES8000HES8000H2016-08-31
10815288010262AEM® Handle HoodedES8000HLES8000HL2016-08-31

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Primary DI, Brand, Company table
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B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDGEI2026-10-20
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B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
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B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
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00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
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