Mini Twin

GUDID 00885797692184

STD EDG MINILP 018 W/O HK 5-5 20EA

Rmo, Inc.

Orthodontic bracket, metal
Primary Device ID00885797692184
NIH Device Record Key7ada7acb-09f0-4a7e-a5c0-16e548e29b05
Commercial Distribution StatusIn Commercial Distribution
Brand NameMini Twin
Version Model NumberKM13500
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
GS100885797692184 [Primary]

FDA Product Code

EJFBracket, Metal, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-10
Device Publish Date2024-09-02

On-Brand Devices [Mini Twin]

00885797692214STD EDG MINILP 022 HK/345 5-5 20EA
00885797692207STD EDG MINILP 022 W/O HK 5-5 20EA
00885797692191STD EDG MINILP 018 HK/345 5-5 20EA
00885797692184STD EDG MINILP 018 W/O HK 5-5 20EA
00885797652812ROTH MINI LOW PROFILE 022 HK/345 5-5 20EA

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