FDA.reportPublic FDA data

AEM® Shield Disposable Electrode, L-Diamond

Primary DI
20815288014229
Brand
AEM® Shield Disposable Electrode, L-Diamond
Company
ENCISION, INC.
Model
FC0311-45+
Catalog number
FC0311-45+
Published
2022-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
20815288014229PackageGS110In Commercial Distribution
10815288014222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2081528801422920815288014229
1081528801422210815288014222

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
612250175
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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