FDA.report

E-LINE

Primary DI
04055207019917
Brand
E-LINE
Company
Richard Wolf GmbH
Model
8701518
Catalog number
8701518
Device description
URETERORENOSCOPE 5° 4.5/6.5FR WL 430MM semi-rigid, with straight ocular lens, working channel 3.4Fr, atraumatic distal tip, TL 565mm, fiber image car
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
04055207019917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207019917040552070199174055207019917

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
Length430Millimeter

Sterilization Methods

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

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

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