Home GUDID 08714729993865 ORISE™ Gel
Primary DI 08714729993865
Brand ORISE™ Gel
Company BOSTON SCIENTIFIC CORPORATION
Model M00519230
Catalog number M00519230
Device description Submucosal lifting agent with needle.
Published 2019-07-29
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 PLL Submucosal injection agent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PLL Submucosal Injection Agent Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08714729993865 Package GS1 10 In Commercial Distribution 08714729993858 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729993865 08714729993865 8714729993865 08714729993858 08714729993858 8714729993858
GMDN Terms# Term, Definition table Term Definition Submucosal lift solution/gel A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g., polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. It is typically a gel-like emulsion (e.g., containing fats and/or salts), and may include a dye. This is a single-use device.
Regulatory Flags# DUNS number 021717889 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 false 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 00724995231866 ASCENDO submucosal lifting agent US Endoscopy PLL 2024-09-02 10724995231863 ASCENDO submucosal lifting agent THE STANDARD CO.,LTD. PLL 2024-09-02 08809380057473 Blue Eye THE STANDARD CO.,LTD. PLL 2024-08-16 08809380057480 Blue Eye The Standard Co., Ltd. PLL 2024-08-16 08809380050207 Blue Eye THE STANDARD CO.,LTD. PLL 2023-07-19 08809380050214 Blue Eye The Standard Co., Ltd. PLL 2023-07-19 00724995221614 Ascendo US Endoscopy PLL 2023-07-11 20724995221618 Ascendo US Endoscopy PLL 2023-07-11 06932503562515 BlueBoost(TM) Submucosal Injectable Solution Micro-Tech (Nanjing) Co., Ltd. PLL 2023-06-28 06932503562522 BlueBoost(TM) Submucosal Injectable Solution Micro-Tech (Nanjing) Co., Ltd. PLL 2023-06-28 16932503562512 MT Micro-Tech (Nanjing) Co., Ltd. PLL 2023-06-28 16932503562529 MT Micro-Tech (Nanjing) Co., Ltd. PLL 2023-06-28 04260206311003 LiftUp Ovesco Endoscopy AG PLL 2022-08-22 04260206310990 LiftUp Ovesco Endoscopy AG PLL 2022-08-22 04260206311355 LiftUp Kit Ovesco Endoscopy AG PLL 2022-08-22 05391530190466 Eleview 5mL COSMO TECHNOLOGIES LIMITED PLL 2022-04-01 05391530190459 Eleview 5mL COSMO TECHNOLOGIES LIMITED PLL 2022-04-01 16972011720240 EndoClot SIS EndoClot Plus Co.,Ltd. PLL 2021-11-16 16972011720257 EndoClot SIS EndoClot Plus Co.,Ltd. PLL 2021-11-16 26972011720247 EndoClot SIS EndoClot Plus Co.,Ltd. PLL 2021-11-16 26972011720254 EndoClot SIS EndoClot Plus Co.,Ltd. PLL 2021-11-16 16972011720226 EndoClot EndoClot Plus Co.,Ltd. PLL 2021-06-23 26972011720223 EndoClot EndoClot Plus Co.,Ltd. PLL 2021-06-23 05391530190367 Eleview COSMO TECHNOLOGIES LIMITED PLL 2021-03-28 05391530190008 Eleview COSMO TECHNOLOGIES LIMITED PLL 2021-03-28 00893029002243 EverLift GI Supply, Inc. PLL 2021-02-18 00893029002229 EverLift GI Supply, Inc. PLL 2021-02-18 10893029002240 EverLift GI Supply, Inc. PLL 2021-02-18 16972011720219 EndoClot EndoClot Plus Co.,Ltd. PLL 2021-02-10 26972011720216 EndoClot EndoClot Plus Co.,Ltd. PLL 2021-02-10