Home GUDID 00821925037915 GYRUS ACMI
Primary DI 00821925037915
Brand GYRUS ACMI
Company Gyrus ACMI, LLC
Model 004942-901
Device description PLEATMAN SAC,Disposable Tissue Removal System
Published 2016-10-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile 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 00821925009936 Package GS1 20 Not in Commercial Distribution 00821925037915 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 00821925009936 00821925009936 821925009936 0821925009936 00821925037915 00821925037915 821925037915 0821925037915
GMDN Terms# Term, Definition table Term Definition Tissue extraction bag An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821925019157 VOCOM 143000 2015-10-24 00821925019164 GYRUS ACMI, INC 143001 2015-10-24 00821925019171 GYRUS ACMI, INC 143002 2015-10-24 00821925019225 GYRUS ACMI, INC 143006 2015-10-24 00821925019232 GYRUS ACMI, INC 143007 2015-10-24 00821925019249 GYRUS ACMI, INC 143008 2015-10-24 00821925019300 GYRUS ACMI, INC 143003 2015-10-24 00821925019317 GYRUS ACMI, INC 143004 2015-10-24 00821925019324 GYRUS ACMI, INC 143005 2015-10-24 00821925012738 EVONOS GMBH & Co. Kg 130015 2018-09-04 00821925012783 EVONOS 130020 2018-09-06 00821925012790 EVONOS 130021-ENT 2018-09-06 00821925012806 EVONOS 130022 2018-09-06 00821925012813 EVONOS 130023 2018-09-06 00821925012820 EVONOS 130024 2018-09-06 00821925012837 Gyrus ACMI 130025-ENT 2018-09-06 00821925012929 EVONOS 130038 2018-09-06 00821925013001 EVONOS 130201 2018-09-10 00821925013018 EVONOS 130202 2018-09-10 00821925013025 EVONOS 130203 2018-09-10
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