FDA.reportPublic FDA data

AEM® Monitor

Primary DI
10815288014147
Brand
AEM® Monitor
Company
ENCISION, INC.
Model
EM3+
Catalog number
EM3+
Published
2022-02-04
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122383000EM3 AEM MONITOR AEM CONNECTORSEncision, Inc.2013-01-10GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815288014147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081528801414710815288014147

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

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