FDA.report

MAMBA VISION

Primary DI
04055207063477
Brand
MAMBA VISION
Company
Richard Wolf GmbH
Model
7315006
Catalog number
7315006
Device description
SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, contro
Published
2018-04-10
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

Product Code Classifications

CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207063477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207063477040552070634774055207063477

GMDN Terms

TermDefinition
Flexible video cystoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device.

Device Sizes

TypeValueUnit
Length400Millimeter

Sterilization Methods

Method
Hydrogen Peroxide

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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