Home GUDID 00821925013650 Gyrus ACMI
Primary DI 00821925013650
Brand Gyrus ACMI
Company Gyrus ACMI, LLC
Model 130324
Device description CASE FOR 18 SCHEER INSTRUMENTS
Published 2018-09-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name FSM Tray, Surgical, Instrument LRC INSTRUMENT, ENT MANUAL SURGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1 LRC Instrument, Ent Manual Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925013650 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 00821925013650 00821925013650 821925013650 0821925013650
GMDN Terms# Term, Definition table Term Definition Middle ear file/rasp A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 00190776422011 Millennium Avalign Technologies, Inc. FSM 2026-07-24 00840536823717 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 00840536823724 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 07640221370846 SCALA SpineArt SA FSM 2026-07-24 07640221370853 SCALA SpineArt SA FSM 2026-07-24 07640221370860 SCALA SpineArt SA FSM 2026-07-24 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 00198506091896 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-22 00198506091902 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-22 00198506091971 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-22 00198506093623 ELMED INCORPORATED ELMED INCORPORATED LRC 2026-07-22 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