Home GUDID 10809160133798 AVID TruCustom
Primary DI 10809160133798
Brand AVID TruCustom
Company AVID MEDICAL, INC.
Model ADVM042-05_0003
Published 2017-03-20
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 OGD Custom anesthesia tray
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OGD Custom Anesthesia Tray Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20809160133795 Package GS1 2 Not in Commercial Distribution 10809160133798 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20809160133795 20809160133795 10809160133798 10809160133798
GMDN Terms# Term, Definition table Term Definition General surgical procedure kit, non-medicated, single-use A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 015623119 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Expiration 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 10809160522936 Halyard AVID MEDICAL, INC. OGD 2026-06-08 10809160523018 Halyard AVID MEDICAL, INC. OGD 2026-06-08 10194717116219 Regard™ ROI CPS, LLC OGD 2022-10-05 10194717115106 Regard™ ROI CPS, LLC OGD 2022-03-22 10194717113881 Regard™ ROI CPS, LLC OGD 2021-11-19 10195594417451 CARDINAL HEALTH Cardinal Health 200, LLC OGD 2021-11-05 10193489361940 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. OGD 2021-08-27 10194717112761 Regard™ ROI CPS, LLC OGD 2021-07-28 10194717110590 Regard™ ROI CPS, LLC OGD 2021-05-10 10194717109730 Regard™ ROI CPS, LLC OGD 2021-02-15 10194717109372 Regard™ ROI CPS, LLC OGD 2021-01-14 10194717108924 Regard ROI CPS, LLC OGD 2020-12-10 10194717107675 Regard™ ROI CPS, LLC OGD 2020-06-25 10194717106982 Regard™ ROI CPS, LLC OGD 2020-01-23 10194717101222 Regard™ ROI CPS, LLC OGD 2019-12-23 10194717103042 Regard™ ROI CPS, LLC OGD 2019-12-10 10194717102434 Regard™ ROI CPS, LLC OGD 2019-11-01 10326053117340 Regard™ Resource Optimization & Innovation, L.L.C. OGD 2019-09-18 10326053114363 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2018-03-28 10326053108713 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2016-12-23 10326053108737 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2016-12-23 10326053100885 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2016-12-21 10326053108317 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2016-12-20 10326053107129 Regard™ RESOURCE OPTIMIZATION & INNOVATION, L.L.C. OGD 2016-12-05 10809160108031 AVID TruCustom AVID MEDICAL, INC. OGD 2016-10-03 10809160107317 AVID TruCustom AVID MEDICAL, INC. OGD 2016-09-28 10809160106143 AVID TruCustom AVID MEDICAL, INC. OGD 2016-09-20 10809160105177 AVID TruCustom AVID MEDICAL, INC. OGD 2016-09-19 10809160088395 AVID TruCustom AVID MEDICAL, INC. OGD 2016-09-15 10809160088708 AVID TruCustom AVID MEDICAL, INC. OGD 2016-09-15