AED

GUDID 00848657020701

Resectoscope sheath for standard irrigation with standard obturator

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Resectoscope
Primary Device ID00848657020701
NIH Device Record Keycdbc9088-fcb2-407d-ae58-b7e26d5959f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED
Version Model Number32-4291
Company DUNS839138955
Company NameNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848657020701 [Primary]

FDA Product Code

FJLRESECTOSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848657020701]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-10-22
Device Publish Date2017-06-30

On-Brand Devices [AED]

00848657086363Tishler-Morgan GYN Forceps, 20cm
00848657086356Tishler-Morgan GYN Forceps, 20cm
00848657086349Tishler-Baby GYN Forceps, 25cm
00848657086332Tishler-Baby GYN Forceps, 20cm
00848657086325AED Kevorkian-Pacific GYN Forceps, 20cm
00848657086318AED Burke GYN Forceps, 20cm
00848657086301AED Micro HD Ureteroscope
00848657086295AED TRU-VU Laser Resectoscope System
00848657085953Tru Vu Operating Hysteroscope, 8.5mm x 18FR
00848657085946Tru Vu Operating Hysteroscope, 6.3mm x 12FR
00848657085939Tru Vu Operating Hysteroscope, 5.8mm x 11FR
00848657085922Tru Vu Operating Hysteroscope, 6.5mm x 9FR
00848657085915Tru Vu Mini Palpation Probe, 5FR, 40cm
00848657085908Tru Vu Mini Trocar/Cannula, 2mm, 9.5cm
00848657085892Tru Vu Mini Button Electrode, 5FR, 40cm
00848657085885Tru Vu Mini Trocar/Cannula, 3.5mm, 20cm
00848657085878Tru Vu Mini Trocar/Cannula, 3.5mm, 15cm
00848657085861AED Sinuscope 2.7mm x 70 degree, 100mm
00848657085854AED Sinuscope 2.7mm x 70 degree, 170mm
00848657085762AED ENDOPRO-CAM®Portable HD Endoscope Video System
00848657085755Tru Vu Mini Operative Laparoscope, 3.5mm x 30cm, 5FR Channel
00848657085304AED Brow Lift Retractor Set
00848657085298AED Brow Lift Retractor
008486570849251mm Cup Forcep, D/A, 35cm WL
00848657084918ESS-WA22367A Bipolar Working Element
008486570849014mm Diameter Mushroom Punch #521.26
008486570848955mm Sinus Backbiter 2.5mm Cut #525.13
00848657084888Pointed Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
00848657084871Hook Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
00848657084864Smooth Fenestrated Mini-Op Lap Grasper, Semi-Rigid, 5FR
00848657084857Blunt Scissor Mini-Op Lap Forcep, Semi-Rigid, 5FR
00848657084840Biopsy Mini-Op Lap Grasper, Semi-Rigid, 5FR
00848657084833Alligator Fenestrated Mini-Op Lap Grasper, Semi-Rigid, 5FR
00848657084352AED Kerrison 2mm Cervical Custom
00848657083584AED Kerrison, 1mm x 200mm
00848657066945AED Composite Axial Handle Needle Holder, 45cm, Curved Right Jaw with T/C Inserts
00848657066938Composite Axial Handle Needle Holder, 36cm, Curved Right Jaw with T/C Inserts
00848657066921AED Composite Axial Handle Needle Holder, 45cm, Curved Left Jaw with T/C Inserts
00848657066914AED Composite Axial Handle Needle Holder, 45cm, Straight Jaw with T/C Inserts
00848657066891AED Axial Handle Needle Holder, Curved Right Jaw with T/C Inserts
00848657066884AED Axial Handle Needle Holder, Curved Left Jaw with T/C Inserts
00848657066877AED Axial Handle Needle Holder, Straight Jaw with T/C Inserts
00848657066860Laparoscopic Flexible Retractor Triangle Shape
00848657066853Laparoscopic Flexible Retractor Large D Shape
00848657066846Laparoscopic Spatula with Irrigation, 5mm X 45cm
00848657066839Laparoscopic Spatula with Irrigation, 5mm X 33cm
00848657066822Laparoscopic J-Hook, 5mm X 45cm
00848657066815Laparoscopic J-Hook, 5mm X 33cm
00848657066808Laparoscopic L-Hook, 5mm X 45cm
00848657066792Laparoscopic L-Hook, 5mm X 33cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.