FDA.reportPublic FDA data

FLI Twin

Primary DI
00885797526977
Brand
FLI Twin
Company
Rmo, Inc.
Model
M05150
Device description
FLI TWIN MBT MX 1-2BI 022R/L 0A -7T GIN
Published
2024-09-04
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
EJFBracket, Metal, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885797526977PrimaryGS10
00000008857972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797526977008857975269778857975269770885797526977
00000008857972000000088579720000088579720000008857972

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Regulatory Flags#

DUNS number
007058183
Device count
10
DM exempt
true
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
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
00885797099945TruFormK005202024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746141249Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141263Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141454Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141461Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141515Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141522Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175442Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746175459Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746176296Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746176302Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746161575Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175954Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175961Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175978Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175985Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176159Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176166Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176753Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176760Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176951Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746176968Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177132Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177149Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177156Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746177163Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26