OrthoPediatrics PediNail Intramedullary Nailing System 10-1500-3032

GUDID 00841132118238

4.5MM x 32MM CORTICAL SCREW

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit
Primary Device ID00841132118238
NIH Device Record Key09de7054-7d02-4f38-a904-015993cb6329
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoPediatrics PediNail Intramedullary Nailing System
Version Model Number10-1500-3032
Catalog Number10-1500-3032
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132118238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-01

On-Brand Devices [OrthoPediatrics PediNail Intramedullary Nailing System]

00841132119341IM FEMORAL NAIL, 10mm x 42cm, Left
00841132119334IM FEMORAL NAIL, 10mm x 40cm, Left
00841132119327IM FEMORAL NAIL, 10mm x 38cm, Left
00841132119310IM FEMORAL NAIL, 10mm x 36cm, Left
00841132119303IM FEMORAL NAIL, 10mm x 34cm, Left
00841132119297IM FEMORAL NAIL, 10mm x 32cm, Left
00841132119280IM FEMORAL NAIL, 10mm x 30cm, Left
00841132119273IM FEMORAL NAIL, 9mm x 42cm, Left
00841132119266IM FEMORAL NAIL, 9mm x 40cm, Left
00841132119259IM FEMORAL NAIL, 9mm x 38cm, Left
00841132119242IM FEMORAL NAIL, 9mm x 36cm, Left
00841132119235IM FEMORAL NAIL, 9mm x 34cm, Left
00841132119228IM FEMORAL NAIL, 9mm x 32cm, Left
00841132119211IM FEMORAL NAIL, 9mm x 30cm, Left
00841132119204IM FEMORAL NAIL, 9mm x 28cm, Left
00841132119198IM FEMORAL NAIL, 8mm x 42cm, Left
00841132119181IM FEMORAL NAIL, 8mm x 40cm, Left
00841132119174IM FEMORAL NAIL, 8mm x 38cm, Left
00841132119167IM FEMORAL NAIL, 8mm x 36cm, Left
00841132119150IM FEMORAL NAIL, 8mm x 34cm, Left
00841132119143IM FEMORAL NAIL, 8mm x 32cm, Left
00841132119136IM FEMORAL NAIL, 8mm x 30cm, Left
00841132119129IM FEMORAL NAIL, 8mm x 28cm, Left
00841132119112IM FEMORAL NAIL, 8mm x 26cm, Left
00841132119105IM FEMORAL NAIL, 8mm x 24cm, Left
00841132119099IM FEMORAL NAIL, 7mm x 38cm, Left
00841132119082IM FEMORAL NAIL, 7mm x 36cm, Left
00841132119075IM FEMORAL NAIL, 7mm x 34cm, Left
00841132119068IM FEMORAL NAIL, 7mm x 32cm, Left
00841132119051IM FEMORAL NAIL, 7mm x 30cm, Left
00841132119044IM FEMORAL NAIL, 7mm x 28cm, Left
00841132119037IM FEMORAL NAIL, 7mm x 26cm, Left
00841132119020IM FEMORAL NAIL, 7mm x 24cm, Left
00841132119013IM FEMORAL NAIL, 7mm x 22cm, Left
00841132119006IM FEMORAL NAIL, 7mm x 20cm, Left
00841132118993IM FEMORAL NAIL, 7mm x 18cm, Left
00841132118986IM FEMORAL NAIL, 7mm x 16cm, Left
00841132118979IM FEMORAL NAIL, 7mm x 14cm, Left
00841132118962IM FEMORAL NAIL, 7mm x 12cm, Left
00841132118955IM FEMORAL NAIL, 10mm x 42cm, Right
00841132118948IM FEMORAL NAIL, 10mm x 40cm, Right
00841132118931IM FEMORAL NAIL, 10mm x 38cm, Right
00841132118924IM FEMORAL NAIL, 10mm x 36cm, Right
00841132118917IM FEMORAL NAIL, 10mm x 34cm, Right
00841132118900IM FEMORAL NAIL, 10mm x 32cm, Right
00841132118894IM FEMORAL NAIL, 10mm x 30cm, Right
00841132118887IM FEMORAL NAIL, 9mm x 42cm, Right
00841132118870IM FEMORAL NAIL, 9mm x 40cm, Right
00841132118863IM FEMORAL NAIL, 9mm x 38cm, Right
00841132118856IM FEMORAL NAIL, 9mm x 36cm, Right
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