FDA.reportPublic FDA data

AccuMedx

Primary DI
00850059707548
Brand
AccuMedx
Company
Accumedx, LLC
Model
AMMSC-33
Device description
Monopolar Curved Scissors 17mm Blade 5mm x 330mm
Published
2024-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850059707555PackageGS110In Commercial Distribution
00850059707562PackageGS14In Commercial Distribution
00850059707548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059707555008500597075558500597075550850059707555
00850059707562008500597075628500597075620850059707562
00850059707548008500597075488500597075480850059707548

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096236324
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059707579AccuMedxAMMSS-332024-01-23
00850059707005AccuMedxAMVN-1202024-01-23
00850059707012AccuMedxAMVN-1502024-01-23
00850059707067AccuMedxAM5-1002024-01-23
00850059707098AccuMedxAM5-1502024-01-23
00850059707128AccuMedxAM12-1002024-01-23
00850059707159AccuMedxAM12-1502024-01-23
00850059707180AccuMedxAM15-1002024-01-23
00850059707210AccuMedxAM15-1502024-01-23
00850059707241AccuMedxAMO5-1002024-01-23
00850059707272AccuMedxAMO5-1502024-01-23
00850059707302AccuMedxAMO12-1002024-01-23
00850059707333AccuMedxAMO12-1502024-01-23
00850059707364AccuMedxAMO15-1002024-01-23
00850059707395AccuMedxAMO15-1502024-01-23
00850059707425AccuMedxAMSI-332024-01-23
00850059707456AccuMedxAMSI-452024-01-23
00850059707487AccuMedxAMSI-33S2024-01-23
00850059707517AccuMedxAMSI-45S2024-01-23
00850059707609AccuMedxAMMGP-332024-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07