Home GUDID 00821925022621 GYRUS ACMI
Primary DI 00821925022621
Brand GYRUS ACMI
Company Gyrus ACMI, LLC
Model 70135060
Device description STERILIZATION CASE FOR TRIALS STEAM AUTOCLAVABLE ULTEM, STAINLESS STEEL
Published 2018-09-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FSM TRAY, SURGICAL, INSTRUMENT
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925022621 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 00821925022621 00821925022621 821925022621 0821925022621
GMDN Terms# Term, Definition table Term Definition Device sterilization/disinfection container, reusable A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00190776421991 Millennium Avalign Technologies, Inc. FSM 2026-07-23 00190776422004 Millennium Avalign Technologies, Inc. FSM 2026-07-23 18059015378368 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378375 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378382 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 00841731153258 ARTEMIS FUZE VILEX LLC FSM 2026-07-22 00841731153265 ARTEMIS TAKEDOWN VILEX LLC FSM 2026-07-22 B803PW12A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW14G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW18A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW20 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW22A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW26A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW30A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW32A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW40A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW6G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 00840606195737 Viaduct SPINAL ELEMENTS, INC. FSM 2026-07-20 00843059127478 Lattus TEDAN SURGICAL INNOVATIONS, L.L.C. FSM 2026-07-20 07613327602241 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602296 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602302 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602326 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602418 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663518 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663525 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663532 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663549 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663556 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327663563 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17