FDA.reportPublic FDA data

AEM® Monitor

Primary DI
10815288012754
Brand
AEM® Monitor
Company
ENCISION, INC.
Model
EM3
Catalog number
EM3
Published
2016-08-31
Public version status
Update
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
10815288012754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081528801275410815288012754

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).

Regulatory Flags#

DUNS number
612250175
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21