FDA.reportPublic FDA data

RMO

Primary DI
00885797095725
Brand
RMO
Company
Rmo, Inc.
Model
F00026
Device description
ELG COIL SPG 008X028 OPEN
Published
2024-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ECOSpring, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797095725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797095725008857970957258857970957250885797095725

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007058183
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885797644862TruLockJ040202024-08-23
00885797644879TruLockJ040212024-08-23
00885797664891TruLockJ040222024-08-23
00885797664907TruLockJ040232024-08-23
00885797664914TruLockJ040242024-08-23
00885797018403OrthonolA07408-12024-09-04
00885797526977FLI TwinM051502024-09-04
00885797019134ThermaloyA077102024-09-03
00885797099815TruFormK003292024-09-03
00885797099822TruFormK003302024-09-03
00885797099839TruFormK003312024-09-03
00885797099846TruFormK003322024-09-03
00885797099853TruFormK003332024-09-03
00885797099860TruFormK003342024-09-03
00885797099884RMOK004552024-09-03
00885797099891TruFormK005102024-09-03
00885797099907TruFormK005122024-09-03
00885797099914TruFormK005142024-09-03
00885797099921TruFormK005162024-09-03
00885797099938TruFormK005182024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746203992Stainless Steel SpringAMERICAN ORTHODONTICS CORPORATIONECO2026-04-21
10371347023111Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023128Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023135Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023142Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023159Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023166Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023173Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023180Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
10371347023197Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2026-04-14
07908611215161ORTHODONTIC TORQUE SPRING 17X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215178ORTHODONTIC TORQUE SPRING 17X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215185ORTHODONTIC TORQUE SPRING 17X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215192ORTHODONTIC TORQUE SPRING 18X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215208ORTHODONTIC TORQUE SPRING 18X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215215ORTHODONTIC TORQUE SPRING 18X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215222ORTHODONTIC TORQUE SPRING 19X25 SMALL 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215239ORTHODONTIC TORQUE SPRING 19X25 MEDIUM 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
07908611215246ORTHODONTIC TORQUE SPRING 19X25 LARGE 10 UN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECO2026-01-12
10371347019374Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019381Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019398Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019404Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-27
10371347019411Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347019428Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-12-26
10371347014577Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-11-15
10371347014553Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014560Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014584Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27
10371347014591Advance Dental ProductsThe Atlanta Dental Supply CompanyECO2024-08-27