FDA.reportPublic FDA data

Megadyne

Primary DI
10614559102237
Brand
Megadyne
Company
MEGADYNE MEDICAL PRODUCTS, INC.
Model
3019A
Device description
Stainless Steel, Electrosurgical Laparoscopic Electrode with Indicator, Spatula, Long, 38 cm., Reusable, For Use With Hand Control Pencil
Published
2020-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
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
K040699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040699000LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)Megadyne Medical Products, Inc.2004-06-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30614559102231PackageGS12Not in Commercial Distribution
10614559102237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061455910223130614559102231
1061455910223710614559102237

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
185444825
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10614559100639Megadyne007500752016-12-08
10614559100943Mega 2000082508252018-09-05
10614559105177Mega SoftM2K01M2K012018-09-05
10614559105184Mega SoftM2K02M2K022018-09-05
10614559105191Mega SoftM2K03M2K032018-09-05
10614559105207Mega SoftM2K04M2K042018-09-05
10614559105214Mega SoftM2K05M2K052018-09-05
10614559100936Mega 2000080008002016-12-11
10614559104590LAPAROSCOPIC TUBING2390J2390J2020-08-11
10614559104606SPECULUM TUBING2395J2395J2020-08-14
10614559105597MEGADYNEMEGEN1MEGEN12020-08-14
10614559105399Megadyne2145J2145J2018-09-04
10614559105429CHARCOAL FILTER2220J2220J2018-09-04
10614559105573MEGADYNE251010J251010J2020-08-03
10614559100042Megadyne000900092016-12-01
10614559100080EZ Clean001200122016-12-01
10614559100097Megadyne0012A0012A2016-12-01
10614559100103Megadyne0012AM0012AM2016-12-01
10614559100110Megadyne0012M0012M2016-12-01
10614559100127Megadyne001300132016-12-02

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Primary DI, Brand, Company table
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