FDA.report

Uretero-Renoscope,430mm,rigid,distal end 7.5/10Ch.,work.channel 1.67x1.85mm(5Ch)

Primary DI
EMAH35003020
Brand
Uretero-Renoscope,430mm,rigid,distal end 7.5/10Ch.,work.channel 1.67x1.85mm(5Ch)
Company
mahe medical gmbh
Model
35.003.02
Catalog number
35.003.02
Device description
Uretero-Renoscope,430mm,rigid,distal end 7.5/10Ch.,work.channel 1.67x1.85mm(5Ch) Direct.of view:8° to working channel,
Published
2019-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EMAH35003020PrimaryHIBCC0

GMDN Terms

TermDefinition
ResectoscopeAn endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.

Device Sizes

TypeValueUnit
Length430Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+49(0)746592750info@mahe-med.de

Regulatory Flags

DUNS number
342243334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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