FDA.reportPublic FDA data

OES URETERO-RENO FIBERSCOPE

Primary DI
04953170340307
Brand
OES URETERO-RENO FIBERSCOPE
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
OLYMPUS URF TYPE P5
Device description
"""URF-P5 Flex Uretero Fiberscope"""
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBNCholedochoscope and accessories, flexible/rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBNCholedochoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912120000URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEOlympus Corp.1991-08-07FBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170340307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170340307049531703403074953170340307

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""High-level Disinfectant""]"
Ethylene Oxide;High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170437984HALOGEN LAMPMAJ-525N61756012023-04-22
04953170465277AUXILIARY WATER TUBEMAJ-855N34993402025-12-05
04953170452932TRACHEAL INTUBATION FIBERSCOPEOLYMPUS LF-PN44475402022-12-23
04953170437571CONNECTING TUBEMAJ-1503N26450012023-04-22
04953170437588CONNECTING TUBEMAJ-1504N26451012023-04-22
04953170437595CONNECTING TUBEMAJ-1505N26452012023-04-22
04953170437601CONNECTING TUBEMAJ-1508N26453012023-04-22
04953170437625CONNECTING TUBEMAJ-1511N26455012023-04-22
04953170437632CONNECTING TUBEMAJ-1512N26456012023-04-22
04953170437649CONNECTING TUBEMAJ-1513N26457012023-04-22
04953170437656CONNECTING TUBEMAJ-1514N26458012023-04-22
04953170437663CONNECTING TUBEMAJ-1515N26459012023-04-22
04953170437670CONNECTING TUBEMAJ-1516N26460012023-04-22
04953170437687CONNECTING TUBEMAJ-1517N26461012023-04-22
04953170437694CONNECTING TUBEMAJ-1764N30610012023-04-22
04953170437700WATER RESISTANT CAPMD-252N36269012023-04-22
04953170437748Water-resistant capMH-553N36274012023-04-22
04953170438318RETAINING RACKMAJ-840N61790012023-04-22
04953170438325CONNECTOR HANGERMAJ-865N61791012023-04-22
04953170434662ENDOEYE FLEX DEFLECTABLE VIDEOSCOPEOLYMPUS LTF-S190-10N38281332023-04-20

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04055207038512RIWORichard Wolf GmbHFBN2024-08-19
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