FDA.reportPublic FDA data

E Surgical

Primary DI
00813527027579
Brand
E Surgical
Company
NEW DEANTRONICS TAIWAN LTD.
Model
AE301MHCi
Device description
Disposable Microblade Electrode, Insulated, Coated, 2.75''
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061878000ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HCE Surgical, LLC2006-10-24GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813527027579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813527027579008135270275798135270275790813527027579

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Regulatory Flags#

DUNS number
656388953
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813527020426E SurgicalSC08H2026-05-15
00813527020433E SurgicalSC10H2026-05-15
00813527023298E SurgicalAN301Ci2026-05-15
00813527023359E SurgicalAE301Ci2026-05-15
00813527023946E SurgicalEPEN212026-05-15
00813527023960E SurgicalEPEN012026-05-15
00813527024264E SurgicalAT3002026-05-15
00813527024370E SurgicalAB3042026-05-15
00813527024417E SurgicalAB3052026-05-15
00813527024493E SurgicalAB3062026-05-15
00813527024950E SurgicalAN3012026-05-15
00813527025094E SurgicalAL3162026-05-15
00813527025117E SurgicalAL3172026-05-15
00813527025155E SurgicalAL3192026-05-15
00813527025179E SurgicalAL3202026-05-15
00813527027005E SurgicalEP2112026-05-15
00813527027555E SurgicalAE301M2026-05-15
00813527028194E SurgicalBA5102026-05-15
00813527028354E SurgicalEPEN412026-05-15
00813527028378E SurgicalEPEN032026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10