PediFlex Advanced 01-1001-9029

GUDID 00841132145555

PEDIFLEX CONTAINER 2 ID CARD

ORTHOPEDIATRICS CORP.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00841132145555
NIH Device Record Keybfc01e04-c3b6-435f-84a3-e07294d6dae7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediFlex Advanced
Version Model Number01-1001-9029
Catalog Number01-1001-9029
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
EmailRzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132145555 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-30
Device Publish Date2018-03-28

On-Brand Devices [PediFlex Advanced]

00841132146019INSERTER BODY
00841132146002METAL LID, SQUARE
00841132145999INSERTER KNOB, SOLID
00841132145982COLLET, 3.0mm
00841132145975COLLET, 2.5mm
00841132145968COLLET, 2.0mm
00841132145951COLLET, 1.5mm
00841132145692PEDIFLEX CONTAINER 1 ID CARD
00841132145685METAL LID
00841132145678PEDIFLEX TI IMPLANT TRAY
00841132145661PEDIFLEX INSTRUMENT TRAY 1
00841132145654PEDIFLEX ADV - CONTAINER 1
00841132145647PEDIFLEX EXTRACTOR
00841132145630SLOTTED MALLET
00841132145623ROUND TIP 4.5MM X 450MM TI
00841132145616ROUND TIP 4.0MM X 450MM TI
00841132145609ROUND TIP 3.5MM X 400MM TI
00841132145593ROUND TIP 3.0MM X 400MM TI
00841132145586ROUND TIP 2.5MM X 300MM TI
00841132145579ROUND TIP 2.0MM X 300MM TI
00841132145562ROUND TIP 1.5MM X 300MM TI
00841132145555PEDIFLEX CONTAINER 2 ID CARD
00841132145548PEDIFLEX SS IMPLANT TRAY
00841132145531PEDIFLEX INSTRUMENT TRAY 2
00841132145524PEDIFLEX ADV - CONTAINER 2
00841132145517ROUND TIP 4.0MM X 450MM SS
00841132145500ROUND TIP 3.5MM X 400MM SS
00841132145494ROUND TIP 3.0MM X 400MM SS
00841132145487ROUND TIP 2.5MM X 300MM SS
00841132145470ROUND TIP 2.0MM X 300MM SS
00841132145463ROUND TIP 1.5MM X 300MM SS
00841132145456INSERTER TAG
00841132145449PEDIFLEX INSERTER TRAY
00841132145432PEDIFLEX ADV - INSERTER CONTAINER
00841132145425COLLET, 4.5MM
00841132145418COLLET, 4.0MM
00841132145401COLLET, 3.5MM

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