FDA.reportPublic FDA data

Olympus

Primary DI
14042761080153
Brand
Olympus
Company
OLYMPUS Winter & Ibe GmbH
Model
WA22221S
Catalog number
WA22221S
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14042761080153PrimaryGS10
04042761080156Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404276108015314042761080153
04042761080156040427610801564042761080156

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
316957240
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042761005722OlympusA3764AA3764A2016-09-21
04042761005739OlympusA3765AA3765A2016-09-21
04042761077729OlympusWA2P400AWA2P400A2016-09-21
04042761002981OlympusA2250A22502016-09-21
04042761009805OlympusA60210AA60210A2016-09-21
04042761009812OlympusA60211AA60211A2016-09-21
04042761010214OlympusA64310AA64310A2016-09-21
04042761010283OlympusA64610AA64610A2016-09-21
04042761010290OlympusA64610LA64610L2016-09-21
04042761010306OlympusA64620AA64620A2016-09-21
04042761010351OlympusA64820LA64820L2016-09-21
04042761010436OlympusA66070AA66070A2016-09-21
04042761010610OlympusA70959AA70959A2016-09-21
04042761011068OlympusA7517A75172016-09-21
04042761011082OlympusA7519A75192016-09-21
04042761020381OlympusA20975AA20975A2016-09-21
04042761021142OlympusA22073AA22073A2016-09-21
04042761021173OlympusA22083AA22083A2016-09-21
04042761021203OlympusA22087AA22087A2016-09-21
04042761023054OlympusA37000AA37000A2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049197180757RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197180818RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197393782RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197393812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197516976RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517041RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517058RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517065RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
04049197517089RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAS2025-07-30
18904148106336ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
18904148106350ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-05-03
08904148100849ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101409ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101522ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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18904148101577ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101584ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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18904148101614ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101621ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101631ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101829ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101836ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101843ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101850ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101867ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101874ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101884ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
18904148101898ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28