Home GUDID 20888937001444 The RUMI System
Primary DI 20888937001444
Brand The RUMI System
Company Coopersurgical, Inc.
Model UMW676
Device description Disposable Uterine Manipulator Tip; Tip Diameter 6.7mm
Published 2015-09-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LKF Cannula, Manipulator/Injector, Uterine
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20888937001444 Package GS1 5 In Commercial Distribution 00888937001440 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 20888937001444 20888937001444 00888937001440 00888937001440 888937001440 0888937001440
GMDN Terms# Term, Definition table Term Definition Uterine manipulator, single-use A sterile, hand-held manual surgical instrument designed to atraumatically mechanically manipulate the position of the uterus during a gynaecological intervention (e.g., laparoscopy) to enable uterine control and improved visibility of the pelvic anatomy, as well as for chromotubation. The device typically consists of a long shaft with an inflatable balloon at the distal end which is transcervically placed inside the uterus and inflated, via a connected syringe (sometimes included), with sterile saline or air; once inflated, the operator can manipulate the uterus. Deflation is a reverse of the inflation process. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 6 Centimeter
Regulatory Flags# DUNS number 801895244 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850011427378 Titus Medical LLC TITUS MEDICAL LLC LKF 2026-04-20 00850011427385 TITUS MEDICAL TITUS MEDICAL LLC LKF 2026-04-19 20859500005008 FemVue FEMASYS INC. LKF 2026-01-06 30859500005005 FemVue FEMASYS INC. LKF 2026-01-06 00888937029697 ALLY II UPS (Uterine Positioning System) Coopersurgical, Inc. LKF 2025-12-18 00198506017919 ELMED INCORPORATED ELMED INCORPORATED LKF 2025-08-11 00198506017704 ELMED INCORPORATED ELMED INCORPORATED LKF 2025-07-08 00860010540930 Rejoni Ribbed Catheter Rejoni, Inc. LKF 2025-02-18 10860010540937 Rejoni Ribbed Catheter Rejoni, Inc. LKF 2025-02-18 00840306835360 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 00840306835377 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 00840306835384 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 00840306835391 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 00840306835407 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 00840306835544 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2025-02-12 04719894432892 Bioteque Bioteque Taiwan Ltd. LKF 2024-12-06 04719894432908 Bioteque Bioteque Taiwan Ltd. LKF 2024-12-06 04719894432915 Bioteque Bioteque Taiwan Ltd. LKF 2024-12-06 04719894432922 Bioteque Bioteque Taiwan Ltd. LKF 2024-12-06 00840306826177 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2024-05-08 00840306826184 Marina Medical MARINA MEDICAL INSTRUMENTS, INC. LKF 2024-05-08 04719894432571 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432588 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432595 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432601 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432618 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432625 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432755 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432762 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08 04719894432779 Bioteque Bioteque Taiwan Ltd. LKF 2024-04-08