FDA.reportPublic FDA data

Unicycle™

Primary DI
00190707056599
Brand
Unicycle™
Company
ORTHO ORGANIZERS, INC.
Model
4119-903
Device description
Unicycle™ .120" Ligature Ties - White
Published
2018-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBAND, ELASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707056599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707056599001907070565991907070565990190707056599

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwire/bracket ligatureA device intended to hold an orthodontic archwire securely in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie or circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190707068148VARIABLE FORCE 3™ THERMAL NITANIUM® ARCHWIRE104-9672026-01-07
10190707086494Triumph®205-0112026-01-07
00190707086503Triumph®205-206B2026-01-07
10190707086517Triumph®205-206T2026-01-07
10190707086524Triumph®205-207T2026-01-07
10190707086531Triumph®205-207TT2026-01-07
00190707102975Carriere® Motion Pro™425-818C2024-01-16
00190707103002Carriere® Motion Pro™425-820C2024-01-16
00190707103033Carriere® Motion Pro™425-823C2024-01-16
00190707103064Carriere® Motion Pro™425-825C2024-01-16
00190707103095Carriere® Motion Pro™425-827C2024-01-16
00190707075972Maestro® Band Assemblies902-351061E2020-07-14
00190707096755Reveal® Aligners139-61042022-01-06
00190707096762Reveal® Aligners139-61052022-01-06
00190707096779Reveal® Aligners139-61062022-01-06
00190707096786Reveal® Aligners139-61072022-01-06
00190707096793Reveal® Aligners139-61092022-01-06
00190707096809Reveal® Aligners139-61082022-01-06
00190707096816Reveal® Aligners139-61102022-01-06
00190707096823Reveal® Aligners139-61112022-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00371347021028Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021035Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021042Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021059Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021066Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021073Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021080Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021097Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021103Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021110Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021127Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021134Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021141Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021158Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021165Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021172Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021189Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021196Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021202Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021219Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021226Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021233Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021240Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021257Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021264Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021271Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021288Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021295Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021301Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021318Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15