3D

GUDID 00885797100276

DUAL TOP MX DISTAL ARCH ASSORT

Rmo, Inc.

Orthodontic bracket, metal
Primary Device ID00885797100276
NIH Device Record Key21fe5d30-c2f2-4ad8-aa5e-71e6a56a4764
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D
Version Model NumberK00930
Company DUNS007058183
Company NameRmo, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100885797100276 [Primary]

FDA Product Code

DYTMaintainer, Space Preformed, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-11
Device Publish Date2024-09-03

On-Brand Devices [3D]

00885797100276DUAL TOP MX DISTAL ARCH ASSORT
00885797100245WILSON TOOL KIT

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