FDA.report

E-LINE

Primary DI
04055207020180
Brand
E-LINE
Company
Richard Wolf GmbH
Model
8715401
Catalog number
8715401
Device description
CYSTOSCOPE 5° 4.5/6.5FR WL 120MM rigid, with lateral ocular lens, working channel for instruments up to 3Fr, atraumatic distal tip, TL 247mm, fiber i
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
FBOCYSTOURETHROSCOPE
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications

CodeDeviceSpecialtyClass
FBOCystourethroscopeGastroenterology, Urology2
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207020180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207020180040552070201804055207020180

GMDN Terms

TermDefinition
Rigid cystourethroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for biopsy, removal of concretions (small stones), treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.

Device Sizes

TypeValueUnit
Angle5degree
Length120Millimeter

Sterilization Methods

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