FDA.reportPublic FDA data

Active Cord Reusable Bovie

Primary DI
00850025860253
Brand
Active Cord Reusable Bovie
Company
Micro-tech Usa
Model
AEC-03-08
Device description
Active Cord Reusable Bovie
Published
2025-02-28
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
K974793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974793000ELMED ESU 120 M/M DIGITALElmed, Inc.1998-03-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850025860260PackageGS110In Commercial Distribution
00850025860253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850025860260008500258602608500258602600850025860260
00850025860253008500258602538500258602530850025860253

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Regulatory Flags#

DUNS number
079873914
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500258605055-Piece Valve KitBW01-FUJ5-F72025-03-03
00850025860697Air/Water Channel Cleaning AdapterBW01-FUJC-F72025-03-04
008500258607104-Piece Valve KitBW01-FUJ4-F72025-03-04
008500258608713-Piece Valve KitBW01-FUJ3-F72025-03-04
00858276007700Polyp Trap single chamber bulkPT50-50-S2025-09-09
10858276007707Polyp Trap single chamber bulkPT50-50-S2025-09-09
00850025860857CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
00850025860864CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
00850025860901CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
00858276007977CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
00858276007984Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
10850025860854CO2 Source Tubing Adapter Olympus UCRBW02-CO2CONOLY2025-05-12
10850025860861CO2 Source Tubing Adapter Fuji GW100BW02-CO2CONFJ2025-05-12
10850025860908CO2 Source Tubing Filter Adapter OlympusBW02-CO2TUBAOLY2025-05-12
10858276007974CO2 Source Tubing Filter OlympusBW02-CO2TUBOLY2025-05-12
10858276007981Endoscopy Kit - Compliance+ FUJ5 KitKT1A0010A2025-05-12
00850025860802Scope Tip ProtectorBW03-DTPS2025-03-11
00850025860819Scope Tip ProtectorBW03-DTPL2025-03-11
10850025860809Scope Tip ProtectorBW03-DTPS2025-03-11
10850025860816Scope Tip ProtectorBW03-DTPL2025-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215410Disposable Bipolar Forceps, 9", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084963AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05