FDA.reportPublic FDA data

Megadyne

Primary DI
10614559101148
Brand
Megadyne
Company
MEGADYNE MEDICAL PRODUCTS, INC.
Model
0410
Catalog number
0410
Device description
LLETZ Loop Electrode, 10mm wide x 7mm deep, 11.8 cm shaft, orange
Published
2016-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGIElectrocautery, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925478000ELECTROSURGICAL ELECTRODEMegadyne Medical Products, Inc.1994-06-27HGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30614559101142PackageGS112In Commercial Distribution
50614559101146PackageGS1180In Commercial Distribution
10614559101148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3061455910114230614559101142
5061455910114650614559101146
1061455910114810614559101148

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

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

Contacts#

Phone, Email table
PhoneEmail
+18015769669megadyne.udi@megadyne.com
+1(801)576-9669megadyne.udi@megadyne.com

Regulatory Flags#

DUNS number
185444825
Device count
1
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887482196646ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196653ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196707ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196714ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196721ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196738ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196745ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482196752ValleylabASPEN SURGICAL PRODUCTS, INC.HGI2025-10-08
10887482177065BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177560BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177584BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-28
10887482177713BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177737BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177782BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177829BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177867BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177904BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177942BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177966BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482177980BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178000BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178024BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178048BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178062BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178123BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178161BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178208BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178222BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178246BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27
10887482178260BovieASPEN SURGICAL PRODUCTS, INC.HGI2024-08-27