FDA.report

Megadyne

Primary DI
30614559101319
Brand
Megadyne
Company
MEGADYNE MEDICAL PRODUCTS, INC.
Model
0030BN
Device description
Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Bulk Non Sterile
Published
2016-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30614559101319PackageGS150In Commercial Distribution
10614559101315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3061455910131930614559101319
1061455910131510614559101315

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+18015769669megadyne.udi@megadyne.com

Regulatory Flags

DUNS number
185444825
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10705036046523Megadyne2255JTES2255JTES2025-06-18
10614559104842Mega Soft084708472023-05-17
10614559104859Mega Soft084808482023-05-17
30614559104051Megadyne0019BN2016-12-07
30614559104167Megadyne0014MP2018-09-04
30614559104181ZIP Pen25402016-12-14
30614559104198ZIP Pen25602016-12-14
30614559104990MEGADYNE2525-10BN2019-02-01
10614559105573MEGADYNE251010J2020-08-03
10614559100042Megadyne00092016-12-01
10614559100080EZ Clean00122016-12-01
10614559100097Megadyne0012A2016-12-01
10614559100103Megadyne0012AM2016-12-01
10614559100110Megadyne0012M2016-12-01
10614559100127Megadyne00132016-12-02
10614559100134Megadyne0013M2016-12-02
10614559100141Megadyne00142016-12-06
10614559100158Megadyne0014A2016-12-06
10614559100165Megadyne0014AM2016-12-06
10614559100172Megadyne0014M2016-12-06

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00198506089732ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-20
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08800020108319DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108326DENSITY TipJeisys Medical Inc.GEI2026-03-16
08800020108395POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108401POTENZAJeisys Medical Inc.GEI2026-03-16
08800020108425POTENZAJeisys Medical Inc.GEI2026-03-16
00198506089565ELMED INCORPORATEDELMED INCORPORATEDGEI2026-03-13
10884450587796STAR™Merit Medical Systems, Inc.GEI2026-03-11
10884450587802STAR™Merit Medical Systems, Inc.GEI2026-03-11
08800020107299POTENZA TipJeisys Medical Inc.GEI2026-03-10
B382SD40060510052E00Surgical DirectSurgical Direct, Inc.GEI2026-03-09