Home GUDID 00844505014403 ApollOS
Primary DI 00844505014403
Brand ApollOS
Company Grace Medical, Inc.
Model 800
Device description ApollOS™
Published 2024-05-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name LRC Instrument, Ent Manual Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LRC Instrument, Ent Manual Surgical Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10844505014400 Package GS1 10 In Commercial Distribution 00844505014403 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 10844505014400 10844505014400 00844505014403 00844505014403 844505014403 0844505014403
GMDN Terms# Term, Definition table Term Definition Mouthguard, single-use A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during surgery or intubation. It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth. This is a single-use device.
Regulatory Flags# DUNS number 030849173 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00844505014762 BONE WAX APPLICATOR 900-001 2026-08-27 00844505012508 Cartilage MACROTOME Handle 990-103 2021-10-29 00844505012515 Cartilage MACROTOME Module 990-104 2021-10-29 00844505012522 Cartilage MACROTOME Tissue Support 990-106 2021-10-29 00844505007139 CARTILAGE MICROTOME 990-001 2018-09-21 00844505009010 CARTILAGE MICROTOME MODULE 990-004 2018-09-21 00844505010399 CARTILAGE MICROTOME HANDLE 990-003 2018-09-21 00844505010405 TISSUE SUPPORT DIAL 990-006 2018-09-21 00844505014786 FEATHERVAC, ECLIPSE 906-102 2026-08-18 00844505014793 FEATHERVAC, ECLIPSE FLAT RIBBON 906-103 2026-08-18 00844505014625 HOUGH FLAP KNIFE 999-204 2026-03-27 00844505014632 THOMASSIN DISSECTOR 999-205 2026-03-27 00844505010269 TITANIUM/FLUOROPLASTIC PISTON 409-600 2026-02-03 00844505014526 GRACE PISTON 412-525 2026-01-07 00844505014533 GRACE PISTON 412-550 2026-01-07 00844505014540 GRACE PISTON 412-575 2026-01-07 00844505012249 EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG. EE-0300 2019-12-05 00844505012256 EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG. EE-0330 2019-12-05 00844505012263 EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG. EE-0345 2019-12-05 00844505012270 EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG. EE-0370 2019-12-05
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