FDA.report

VIPER

Primary DI
04055207013700
Brand
VIPER
Company
Richard Wolf GmbH
Model
7325076
Catalog number
7325.076
Device description
FIBER-URETERORENOSCOPE 9.6FR WL 680MM flexible, working channel 3.6Fr, slanted distal tip Ø 6 Fr, TL 1005mm, deflection +270°/-270°, glass fiber ligh
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
FAJCystoscope and accessories, flexible/rigid
FGBUreteroscope and accessories, flexible/rigid

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207013700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207013700040552070137004055207013700

GMDN Terms

TermDefinition
Flexible fibreoptic ureterorenoscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. This is a reusable device.

Device Sizes

TypeValueUnit
Length680Millimeter
Outer Diameter3.2Millimeter

Sterilization Methods

Method
Hydrogen Peroxide
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

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