FDA.reportPublic FDA data

Ortho Traction Pads

Primary DI
00850038184124
Brand
Ortho Traction Pads
Company
ORTHO TRACTION PADS, LLC
Model
RPEP XL
Device description
Round Pad Eyelet Profile XL Chain - RPEP XL
Published
2021-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850038184124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038184124008500381841248500381841240850038184124

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.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
118690675
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850038184001Ortho Traction PadsBPOC2021-12-13
00850038184018Ortho Traction PadsBPRO2021-12-13
00850038184025Ortho Traction PadsLPLP2021-12-13
00850038184032Ortho Traction PadsMPEP2021-12-13
00850038184049Ortho Traction PadsMPLP2021-12-13
00850038184056Ortho Traction PadsRPEP2021-12-13
00850038184063Ortho Traction PadsSPEP2021-12-13
00850038184070Ortho Traction PadsBPOC XL2021-12-13
00850038184087Ortho Traction PadsBPRO XL2021-12-13
00850038184094Ortho Traction PadsLPLP XL2021-12-13
00850038184100Ortho Traction PadsMPEP XL2021-12-13
00850038184117Ortho Traction PadsMPLP XL2021-12-13
00850038184131Ortho Traction PadsSPEP XL2021-12-13
00850038184148Ortho Traction PadsMPEP Larger2021-12-13
00850038184155Ortho Traction PadsMPEP 2 Inch Chain2021-12-13
00850038184162Ortho Traction PadsSOP-92021-12-13
00850038184186Ortho Traction PadsPS-182021-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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