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医疗器械中英文对照--肠胃病学-泌尿学器械 (Gastroenterology-Urology Devices)

(《联邦规章典集》第21篇第876部[21CFR876])
    目录
节号
中译文
原英文
A亚部――总则(General Provisions)
876.1
范围
Scope
876.3
有关上市前批准生效日期的要求
Effective dates of requirement for premarket approval
876.9
联邦食品、药品和化妆品法(Federal Food, Drug, and Cosmetic Act,FDCA)第510(k)节的豁免限制
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
B亚部――诊断器械(Diagnostic Devices)
876.1075
肠胃病学-泌尿学活组织检查器具
Gastroenterology-urology biopsy instrument
876.1300
遥感勘测胃肠可吸收胶囊的成像系统
Ingestible telemetric gastrointestinal capsule imaging system
876.1400
胃部pH电极
Stomach pH electrode
876.1500
内诊镜及附件
Endoscope and accessories
876.1620
排尿动力学测量系统
Urodynamics measurement system
876.1725
胃肠运动监测系统
Gastrointestinal motility monitoring system
876.1735
胃电描记系统
Electrogastrography system
876.1800
尿流或尿量测量系统
Urine flow or volume measuring system
C亚部――监测器械(Monitoring Devices)
876.2040
遗尿警报器
Enuresis alarm
D亚部――修复器械(Prosthetic Devices)
876.3350
阴茎膨胀式植入物
Penile inflatable implant
876.3630
阴茎刚性植入物
Penile rigidity implant
876.3750
睾丸假体
Testicular prosthesis
E亚部――手术器械(Surgical Devices)
876.4020
光纤式输尿管导管
Fiberoptic light ureteral catheter
876.4270
结肠造口杆
Colostomy rod
876.4300
内窥镜式电外科装置及附件
Endoscopic electrosurgical unit and accessories
876.4370
肠胃病学-泌尿学排泄器
Gastroenterology-urology evacuator
876.4440
痔结扎器
Hemorrhoidal ligator
876.4480
电动液压式碎石器
Electrohydraulic lithotriptor
876.4500
机械式碎石器
Mechanical lithotriptor
876.4530
肠胃病学-泌尿学光纤式牵引器
Gastroenterology-urology fiberoptic retractor
876.4560
Ribdam排尿器
Ribdam
876.4590
联锁尿道探子
Interlocking urethral sound
876.4620
输尿管展伸器
Ureteral stent
876.4650
水喷式肾结石排除系统
Water jet renal stone dislodger system
876.4680
输尿管结石排除器
Ureteral stone dislodger
876.4730
手动肠胃病学-泌尿学手术器械及附件
Manual gastroenterology-urology surgical instrument and accessories
876.4770
尿道刀
Urethrotom
876.4890
泌尿科工作台及附件
Urological table and accessories
F亚部 ――治疗器械(Therapeutic Devices)
876.5010
胆道导管及附件
Biliary catheter and accessories
876.5030
控制排泄能力的回肠造口导管
Continent ileostomy catheter
876.5090
耻骨弓上泌尿导管及附件
Suprapubic urological catheter and accessories
876.5130
泌尿导管及附件
Urological catheter and accessories
876.5160
男性尿道夹
Urological clamp for males
876.5210
灌肠工具盒
Enema kit
876.5220
结肠冲洗系统
Colonic irrigation system
876.5250
尿液收集器及附件
Urine collector and accessories
876.5270
植入式电子尿自控设备
Implanted electrical urinary continence device
876.5280
植入机械式/液压式尿自控设备
Implanted mechanical/hydraulic urinary continence device
876.5310
非植入式外围电子自控设备
Nonimplanted, peripheral electrical continence device
876.5320
非植入式电子自控设备
Nonimplanted electrical continence device
876.5365
食管扩张器
Esophageal dilator
876.5450
直肠扩张器
Rectal dilator
876.5470
输尿管扩张器
Ureteral dilator
876.5520
尿道扩张器
Urethral dilator
876.5540
血液存取设备及附件
Blood access device and accessories
876.5600
血液透析用吸附剂可再生的透析液传送系统
Sorbent regenerated dialysate delivery system for hemodialysis
876.5630
腹膜透析系统及附件
Peritoneal dialysis system and accessories
876.5665
血液透析用水净化系统
Water purification system for hemodialysis
876.5820
血液透析系统及附件
Hemodialysis system and accessories
876.5830
带一次性插入物(Kiil型)的吸引透析器
Hemodialyzer with disposable insert (Kiil type)
876.5860
高渗透型血液透析系统
High permeability hemodialysis system
876.5870
吸附剂血液灌注系统
Sorbent hemoperfusion system
876.5880
隔离的肾灌注与输送系统及附件
Isolated kidney perfusion and transport system and accessories
876.5885
人体外组织与细胞培养加工应用的组织培养介质
Tissue culture media for human ex vivo tissue and cell culture processing applications
876.5895
造口冲洗器
Ostomy irrigator
876.5900
造口术袋及附件
Ostomy pouch and accessories
876.5920
失禁用保护外衣
Protective garment for incontinence
876.5955
腹膜-静脉分流管
Peritoneo-venous shunt
876.5970
疝气支撑物
Hernia support
876.5980
胃肠管及附件
Gastrointestinal tube and accessories
876.5990
体外震波碎石机
Extracorporeal shock wave lithotripter