FDA.reportPublic FDA data

E Surgical

Primary DI
00813527023298
Brand
E Surgical
Company
NEW DEANTRONICS TAIWAN LTD.
Model
AN301Ci
Device description
Disposable Needle 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
00813527023298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813527023298008135270232988135270232980813527023298

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
00813527028590E SurgicalRB3490-012026-06-23
00813527028613E SurgicalRB3455-012026-06-23
00813527028637E SurgicalRB0700-212026-06-23
00813527028651E SurgicalRB2000-112026-06-23
00813527028675E SurgicalRB2040-112026-06-23
00813527028699E SurgicalRB4090A-022026-06-23
00813527028712E SurgicalRB4090-022026-06-23
00813527028736E SurgicalRB4050A-022026-06-23
00813527028750E SurgicalRB4050-022026-06-23
00813527028774E SurgicalRB2790-012026-06-23
00813527028798E SurgicalRB2760-012026-06-23
00813527028811E SurgicalRB2790-002026-06-23
00813527028835E SurgicalRB2760-002026-06-23
00813527028859E SurgicalRB4050-012026-06-23
00813527028873E SurgicalRB4050A-012026-06-23
00813527028897E SurgicalRB4090-012026-06-23
00813527028910E SurgicalRB4090A-012026-06-23
00813527029153E SurgicalES3002026-06-23
00813527020426E SurgicalSC08H2026-05-15
00813527020433E SurgicalSC10H2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028613E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028637E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028651E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028675E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028699E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028712E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028736E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028750E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028774E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028798E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028811E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028835E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028859E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028873E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028897E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527028910E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
00813527029153E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
B112S03086NSU200STINGRAY SURGICAL PRODUCTSSTINGRAY SURGICAL PRODUCTS L.L.C.GEI2026-06-10
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09