RMO

GUDID 00000008857972

LINGUAL BUTTONS

Rmo, Inc.

Orthodontic tube
Primary Device ID00000008857972
NIH Device Record Key59f54af2-805b-4bfb-b12c-d24647568ffa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRMO
Version Model NumberFIDTL16
Company DUNS007058183
Company NameRmo, Inc.
Device Count10
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
GS100000008857972 [Unit of Use]
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GS100885797714480 [Primary]
GS100885797714497 [Primary]
GS100885797714503 [Primary]
GS100885797714510 [Primary]
GS100885797714527 [Primary]
GS100885797714534 [Primary]
GS100885797714541 [Primary]
GS100885797714558 [Primary]
GS100885797714565 [Primary]
GS100885797714602 [Primary]
GS100885797717139 [Primary]
GS100885797717146 [Primary]
GS100885797717153 [Primary]
GS100885797717160 [Primary]
GS100885797717177 [Primary]
GS100885797719416 [Primary]
GS100885797719423 [Primary]
GS100885797719430 [Primary]
GS100885797719447 [Primary]
GS100885797719454 [Primary]
GS100885797719461 [Primary]
GS100885797719478 [Primary]
GS100885797719485 [Primary]
GS100885797719492 [Primary]
GS100885797719508 [Primary]
GS100885797719515 [Primary]
GS100885797719522 [Primary]
GS100885797719539 [Primary]
GS100885797719546 [Primary]
GS100885797719553 [Primary]
GS100885797719560 [Primary]
GS100885797719577 [Primary]
GS100885797719584 [Primary]
GS100885797719591 [Primary]
GS100885797719607 [Primary]
GS100885797719614 [Primary]
GS100885797719621 [Primary]
GS100885797719638 [Primary]
GS100885797719645 [Primary]
GS100885797719652 [Primary]
GS100885797719669 [Primary]
GS100885797719676 [Primary]
GS100885797719683 [Primary]
GS100885797719690 [Primary]
GS100885797719706 [Primary]
GS100885797720054 [Primary]
GS100885797720061 [Primary]
GS100885797720078 [Primary]
GS100885797720085 [Primary]
GS100885797720092 [Primary]
GS100885797720108 [Primary]
GS100885797720115 [Primary]
GS100885797720122 [Primary]
GS100885797720139 [Primary]
GS100885797720146 [Primary]
GS100885797720153 [Primary]
GS100885797720160 [Primary]
GS100885797720177 [Primary]
GS100885797720184 [Primary]
GS100885797720191 [Primary]
GS100885797720207 [Primary]
GS100885797720214 [Primary]
GS100885797720221 [Primary]
GS100885797720238 [Primary]
GS100885797720245 [Primary]
GS100885797720252 [Primary]
GS100885797720269 [Primary]
GS100885797720276 [Primary]
GS100885797720283 [Primary]
GS100885797720290 [Primary]
GS100885797720306 [Primary]
GS100885797720313 [Primary]
GS100885797720320 [Primary]
GS100885797720337 [Primary]
GS100885797720344 [Primary]
GS100885797723390 [Primary]
GS100885797723406 [Primary]
GS100885797723413 [Primary]
GS100885797723420 [Primary]
GS100885797723635 [Primary]
GS100885797723642 [Primary]
GS100885797723659 [Primary]
GS100885797723666 [Primary]
GS100885797723673 [Primary]
GS100885797723680 [Primary]
GS100885797723697 [Primary]
GS100885797723703 [Primary]
GS100885797728456 [Primary]
GS100885797728463 [Primary]
GS100885797728470 [Primary]
GS100885797728487 [Primary]
GS100885797728494 [Primary]
GS100885797728500 [Primary]
GS100885797728517 [Primary]
GS100885797787118 [Primary]
GS100885797787125 [Primary]
GS100885797787132 [Primary]
GS100885797787149 [Primary]
GS100885797787156 [Primary]
GS100885797787163 [Primary]
GS100885797787170 [Primary]
GS100885797787187 [Primary]

FDA Product Code

BRWProtector, Dental
DYHAdhesive, Bracket And Tooth Conditioner, Resin
DYJRetainer, Screw Expansion, Orthodontic
DYTMaintainer, Space Preformed, Orthodontic
DYWBracket, Plastic, Orthodontic
DZBHeadgear, Extraoral, Orthodontic
DZCWire, Orthodontic
DZDTube, Orthodontic
DZEImplant, Endosseous, Root-Form
DZNInstruments, Dental Hand
EBZActivator, Ultraviolet, For Polymerization
ECIBand, Elastic, Orthodontic
ECMBand, Preformed, Orthodontic
ECOSpring, Orthodontic
EHPClasp, Preformed
EHYTray, Impression, Preformed
EJFBracket, Metal, Orthodontic
KMYPositioner, Tooth, Preformed
KXRApplicator, Resin
NJMBracket, Ceramic, Orthodontic
ORTBurst Suppression Detection Software For Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-20
Device Publish Date2024-08-12

On-Brand Devices [RMO]

00885797789914ALIGNER PLIER HOLE PUNCH
00000008857989STAINLESS STEEL OPEN-WALL ARCH HOOK, W/BALL END
00000008857972LINGUAL BUTTONS
00885797096340PILOT DRILL
00885797693471Preformed Quad Helix 036 BLUE ELG SIZE 3
00885797693464Preformed Quad Helix 036 BLUE ELG SIZE 2
00885797693457Preformed Quad Helix 036 BLUE ELG SIZE 1
00885797693440Preformed Quad Helix 036 BLUE ELG SIZE 0
00885797610744EXPANSION RAPID BENT DBL ARM 13MM W/KEY
00885797610737EXPANSION RAPID BENT DBL ARM 11MM W/KEY
00885797610720EXPANSION RAPID BENT DBL ARM 9MM W/KEY
00885797610713EXPANSION RAPID BENT DBL ARM 8MM W/KEY
00885797610690EXPANSION RAPID DBL ORTHOGONAL 12MM W/KEY
00885797610683EXPANSION RAPID DBL ORTHOGONAL 10MM W/KEY
00885797610676EXPANSION RAPID DBL ORTHOGONAL 8MM W/KEY
00885797610669EXPANSION MICRO SGLE ARM 11MM W/KEY
00885797610652EXPANSION MICRO SGLE ARM 8MM W/KEY
00885797081469RICKETTS QUAD HELIX UNIT SIZE #2
00885797081452RICKETTS QUAD HELIX UNIT SIZE #1
00885797578037SCREWDRIVER FLAT/HEX
00885797545701FLI SL 3.0 INSTRUMENT
00885797728616NICKEL TITANIUM MOLAR DISTALIZING SPRING .010" X .045" 21" SPOOL
00885797728609NICKEL TITANIUM OPEN COIL SPRING .012" X .045" 21" SPOOL
00885797728593NICKEL TITANIUM OPEN COIL SPRING .012" X .030" 21" SPOOL
00885797728586NICKEL TITANIUM OPEN COIL SPRING .010" X .030" 21" SPOOL
00885797096081NITI DIST SPRG STOPWD.010X.045
00885797096012NITI COMP SPRING OPEN.012X.045
00885797096005NITI COMP SPRING OPEN.012X.030
00885797095992NITI COMP SPRING OPEN.010X.030
00885797095947ELG COIL SPG 007X030 OPEN
00885797095930ELG COIL SPG 007X028 OPEN
00885797095923ELG COIL SPG 010X045 OPEN
00885797095916ELG COIL SPG 010X040 OPEN
00885797095909ELG COIL SPG 010X036 CLOSED
00885797095893ELG COIL SPG 010X036 OPEN
00885797095886ELG COIL SPG 010X032 OPEN
00885797095879ELG COIL SPG 010X030 CLOSED
00885797095862ELG COIL SPG 010X030 OPEN
00885797095855ELG COIL SPG 010X028 OPEN
00885797095848ELG COIL SPG 009X040 OPEN
00885797095831ELG COIL SPG 009X036 OPEN
00885797095824ELG COIL SPG 009X032 CLOSED
00885797095817ELG COIL SPG 009X032 OPEN
00885797095800ELG COIL SPG 009X030 CLOSED
00885797095794ELG COIL SPG 009X030 OPEN
00885797095787ELG COIL SPG 009X028 OPEN
00885797095770ELG COIL SPG 008X036 CLOSED
00885797095763ELG COIL SPG 008X036 OPEN
00885797095756ELG COIL SPG 008X032 OPEN
00885797095749ELG COIL SPG 008X030 CLOSED

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