Home GUDID 00190776299668 Millennium
Primary DI 00190776299668
Brand Millennium
Company Avalign Technologies, Inc.
Model 72-3434003
Device description ELLIK RUBBER BALL ONLY
Published 2023-06-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FFD Evacuator, bladder, manually operated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFD Evacuator, Bladder, Manually Operated Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776299668 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776299668 00190776299668 190776299668 0190776299668
GMDN Terms# Term, Definition table Term Definition Bladder evacuator, reusable A hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 792528510 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04059453040756 Hermann Medizintechnik GmbH Hermann Medizintechnik GmbH FFD 2025-08-25 05906168942228 Dual Action Pump Hand WISMED PL SP Z O O FFD 2025-03-17 05906168942211 Dual Action Pump Foot WISMED PL SP Z O O FFD 2025-03-17 59061689422282 Dual Action Pump Hand WISMED PL SP Z O O FFD 2025-03-17 00810143891249 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FFD 2024-09-27 00810143891256 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FFD 2024-09-27 06936881168789 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 06936881168796 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 06936881168802 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 26936881168783 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 26936881168790 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 26936881168806 Wellead Evacuator Well Lead Medical Co.,Ltd FFD 2024-01-19 05060460843666 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843697 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843727 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843758 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460845707 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460848043 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889374 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889404 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889435 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843680 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843710 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843741 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460843765 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460845714 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060460848050 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889398 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889428 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19 05060590889442 Enteral GBUK ENTERAL LIMITED FFD 2022-10-19
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