FDA.report

E-LINE

Primary DI
04055207019924
Brand
E-LINE
Company
Richard Wolf GmbH
Model
8701533
Catalog number
8701.533
Device description
URETERORENOSCOPE 5° 4.5/6.5FR WL 315MM semi-rigid, with lateral ocular lens, working channel 3Fr, atraumatic distal tip, TL 440mm, fiber image carrie
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207019924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207019924040552070199244055207019924

GMDN Terms

TermDefinition
Rigid ureterorenoscopeAn endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.

Device Sizes

TypeValueUnit
Angle5degree
Length315Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
16971176282921Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282938Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06971176282948Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282952Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282969Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06971176282979Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282983Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
16971176282990Single Use Flexible Video UreteroscopeZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13
06972520300677Endoscopic Video Image ProcessorGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301759Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301766Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301773Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520301780Single-Use Video Flexible UreterorenoscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302794Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302800Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302817Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520302824Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31
06972520303067Endoscopic Video Image Processor HDGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2025-12-31