Home GUDID 00858813002199 Platypus
Primary DI 00858813002199
Brand Platypus
Company GLENROE, LLC
Model AC150-5
Device description PLATYPUS ALIGNER SEATING CHEW 5/PK
Published 2026-06-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name ECS Pusher, Band, Orthodontic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ECS Pusher, Band, Orthodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00858813002199 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 00858813002199 00858813002199 858813002199 0858813002199
GMDN Terms# Term, Definition table Term Definition Orthodontic aligner/retainer seater, single-use A small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.
Regulatory Flags# DUNS number 135854138 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00858813002175 Platypus GLENROE, LLC ECS 2026-06-01 00858813002182 Platypus GLENROE, LLC ECS 2026-06-01 00858813002205 Platypus GLENROE, LLC ECS 2026-06-01 00840018674639 Nordent Manufacturing, Inc. NORDENT MANUFACTURING INC ECS 2026-05-05 00840018662087 Nordent Manufacturing, Inc. NORDENT MANUFACTURING INC ECS 2026-01-29 00840018662155 Nordent Manufacturing, Inc. NORDENT MANUFACTURING INC ECS 2026-01-29 00190707193317 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193324 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193331 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193348 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193355 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193362 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193379 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193386 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00190707193393 Ortho Technology® Ortho Organizers, Inc. ECS 2025-10-23 00371347019797 Advance Dental Products The Atlanta Dental Supply Company ECS 2025-10-02 00371347019803 Advance Dental Products The Atlanta Dental Supply Company ECS 2025-10-02 00889813066041 Darby Dental Supply, LLC DARBY DENTAL SUPPLY, LLC ECS 2024-11-30 00850058951362 Amtouch Aligner Chewies AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. ECS 2024-10-08 00850058951379 Amtouch Aligner Chewies AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. ECS 2024-10-08 00885797097293 Schweickhardt Rmo, Inc. ECS 2024-08-19 00840105223597 ZOLL DENTAL Zoll-Dental ECS 2024-07-29 00843471151273 Young Specialties Young Innovations, Inc. ECS 2024-07-11 00843471151280 Young Specialties Young Innovations, Inc. ECS 2024-07-11 00843471151297 Young Specialties Young Innovations, Inc. ECS 2024-07-11 00843471151303 Young Specialties Young Innovations, Inc. ECS 2024-07-11 00843471151310 Young Specialties Young Innovations, Inc. ECS 2024-07-11 07908611206053 ORTHOCHEWIE ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA ECS 2024-02-27 08800075622747 OSUNG MND OSUNG MND Co., Ltd. ECS 2024-02-19 07898506814176 Quinelato Schobell Industrial Ltda ECS 2023-07-05
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