FDA.reportPublic FDA data

Pediatric Nailing Platform Tibia

Primary DI
00840194428286
Brand
Pediatric Nailing Platform Tibia
Company
ORTHOPEDIATRICS CORP.
Model
01-1510-0042
Catalog number
01-1510-0042
Device description
Radiographic Ruler
Published
2023-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FTYTAPE, MEASURING, RULERS AND CALIPERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTYTape, Measuring, Rulers And CalipersGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194428286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194428286008401944282868401944282860840194428286

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic x-ray rulerA device used in an orthopaedic clinical setting to establish an accurate measurement of length or size related to a bone structure (i.e., length, thickness, or other aspects) when this is being viewed by the surgeon during fluoroscopy. It is a smooth-edged strip, typically made of stainless steel, that is marked in units of length (i.e., inches and/or millimetres) and includes a series of notches and holes that clearly show up on the x-ray image demonstrating the distances of the viewed bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

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Primary DI, Brand, Company table
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04719846017436CharderCHARDER ELECTRONIC CO., LTD.FTY2026-07-14
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00849987002702SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987002733SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003037SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
00849987003044SR ScalesS R INSTRUMENTS, INC.FTY2026-06-23
08809513720069SAEHAN Skinfold CaliperSaehan CorporationFTY2026-05-18
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G4250010My MedicalMy Medical Store LLCFTY2026-05-04
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00842071152956AMT Balloon Measuring DeviceAPPLIED MEDICAL TECHNOLOGY, INC.FTY2026-02-20
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10197344154654MEDLINEMEDLINE INDUSTRIES, INC.FTY2025-07-28
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