FDA.reportPublic FDA data

Olympus

Primary DI
06939029818331
Brand
Olympus
Company
Modern Medical Equipment MFG. Ltd.
Model
PD650
Device description
Pencil, Button Switch, Non-Coated Blade Electrode, Holster, Non-Sterile
Published
2021-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
06939029818331PrimaryGS10
16939029818338Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06939029818331069390298183316939029818331
1693902981833816939029818338

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
527812392
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939029817228OlympusWA98600A2018-04-11
06939029817235OlympusWA98700A2018-04-11
06939029815132OlympusET8652021-05-30
06939029817303OlympusPD650WA98225B2021-05-30
06939029817372OlympusPD735WA98216R2021-05-30
06939029817389OlympusPD635WA98215F2021-05-30
06939029817396OlympusPD635WA98225F2021-05-30
06939029817402OlympusPD635WA98216F2021-05-30
06939029817419OlympusPD635WA98226F2021-05-30
06939029817525OlympusMH432WA98400A2021-05-30
06939029818263OlympusET8652021-05-08
06939029818270OlympusET4562021-05-08
06939029818287OlympusET8652021-05-08
06939029818294OlympusEF4562021-05-08
06939029818317OlympusPD7352021-05-08
06939029818355OlympusPD7352021-05-08
06939029818195OlympusEF4402021-05-07
06939029818201OlympusET8652021-05-07
06939029818218OlympusEF4412021-05-07
06939029818225OlympusET8652021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12
00190776434083MillenniumAvalign Technologies, Inc.GEI2026-10-09
00190776434199MillenniumAvalign Technologies, Inc.GEI2026-10-09
B382SD030861101530Surgical DirectSurgical Direct, Inc.GEI2026-10-09
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