FDA.reportPublic FDA data

NA

Primary DI
07613327055535
Brand
NA
Company
STRYKER CORPORATION
Model
0504881414
Catalog number
0504-881-414
Device description
[Cutting Loop Electrode, .014 wire, 27 Fr ¿ 30 ¿, Only for use with Stryker Resectoscopes 0502-880-401, 0502-880-402, Do not use if package is damaged]
Published
2016-09-23
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
FAJCystoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327055536PackageGS16In Commercial Distribution
07613327055535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332705553637613327055536
07613327055535076133270555357613327055535

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, single-useAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a 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 controlling ring-handles). This is a single-use device intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327631388N/A50275000005027-500-0002026-06-16
07613327631395N/A50275001005027-500-1002026-06-19
07613327632774N/A50275004005027-500-4002026-06-16
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971381254228Single-use Flexible UreteroscopeScivita Medical Technology Co., Ltd.FAJ2026-07-16
00840432200001CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00840432200018CFlex™Verathon Medical (Canada) ULCFAJ2026-05-15
00810116023424Dornier MedTechDORNIER MEDTECH AMERICA, INC.FAJ2026-05-06
00850023925381AptraOtu Medical Inc.FAJ2024-09-30
00850023925398AptraOtu Medical Inc.FAJ2024-09-30
00850023925428WiScope®Otu Medical Inc.FAJ2024-09-30
00850023925435WiScope®Otu Medical Inc.FAJ2024-09-30
04055207038512RIWORichard Wolf GmbHFAJ2024-08-19
04055207008607NARichard Wolf GmbHFAJ2024-08-19
00677964074936ENDO SMARTCAPMEDIVATORS INC.FAJ2024-05-29
07613327616675SPYSTRYKER CORPORATIONFAJ2024-02-27
07613327616736SPYSTRYKER CORPORATIONFAJ2024-02-27
10818634025149AmbuBosma EnterprisesFAJ2023-05-01
10818634025194AmbuBosma EnterprisesFAJ2023-05-01
50724995219241ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219258ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219265ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
50724995219272ENDO SMARTCAPMEDIVATORS INC.FAJ2023-04-28
00848657076135AED Flexible Cystoscopy Biopsy Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076142AED Flexible Cystoscopy Alligator Forcep S/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076159AED Flexible Cystoscopy Alligator Forcep D/A, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00848657076166AED Flexible Cystoscopy Rat Tooth Forcep, 1.8mm x 65cmNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2023-01-25
00860008483706Uro-G Flexible CystoscopeUROVIU CORP.FAJ2022-12-16
00850006759668Aveta Auto 5 Fr Disposable Resecting DeviceMEDITRINA, INC.FAJ2022-08-18
00850023925169WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925176WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925183WiScope®Otu Medical Inc.FAJ2022-04-18
00850023925190WiScope®Otu Medical Inc.FAJ2022-04-18
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)UVISION 360, INC.FAJ2021-08-13