Home GUDID 00817688021995 ESU Shroud
Primary DI 00817688021995
Brand ESU Shroud
Company I.C. MEDICAL, INC.
Model ICM-000-0543
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GCJ Laparoscope, General & Plastic Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817688021995 Primary GS1 0 00817688021278 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817688021995 00817688021995 817688021995 0817688021995 00817688021278 00817688021278 817688021278 0817688021278
GMDN Terms# Term, Definition table Term Definition Surgical plume evacuation system tube A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 616182895 Device count 25 Lot or batch true Manufacturing date on label true No natural rubber latex 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 00198506092183 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-29 00198506092640 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-29 00198506093562 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-29 00198506093838 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-29 B354OSRP80 Retrieval Pouch (Multi Deploy) 8 mm ORANGE SURGICAL INSTRUMENTS, LLC GCJ 2026-07-29 00198506092435 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-28 00198506092855 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-28 00198506093289 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-28 00198506093388 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-28 00842102116452 Deluxe Laparoscopic Instruments FLEXBAR MACHINE CORPORATION GCJ 2026-07-28 14026704645340 WECK TELEFLEX INCORPORATED GCJ 2026-07-28 B382SD901365500 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-28 00190776422110 Millennium Avalign Technologies, Inc. GCJ 2026-07-24 00198506091957 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 00198506092848 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 00198506092862 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-22 14026704645333 WECK TELEFLEX INCORPORATED GCJ 2026-07-21 00198506092176 ELMED INCORPORATED ELMED INCORPORATED GCJ 2026-07-17 00888867561793 Arthrex® ARTHREX, INC. GCJ 2026-07-17 B382SD90781001000 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-17 B382SD9918100 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-17 B382SD1184590 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD12711090 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD1271390 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD1271590 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD13018770 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD13168350 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD23373490 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD770561050 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14 B382SD775011530 Surgical Direct Surgical Direct, Inc. GCJ 2026-07-14