PediFrag 00-1005-5010

GUDID 00841132138199

2.7MM CLAVICLE PLATE, 10 HOLE, RIGHT

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00841132138199
NIH Device Record Key3e701f91-6d58-4f6a-9350-ae95cd7ab29c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediFrag
Version Model Number00-1005-5010
Catalog Number00-1005-5010
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
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com
Phone+1(574)268-6379
EmailRzorn@OrthoPediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132138199 [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 Number2
Public Version Date2018-03-29
Device Publish Date2017-07-30

On-Brand Devices [PediFrag]

008411321383803.5MM CLAVICLE PLATE, 5 HOLE, LEFT
008411321383733.5MM CLAVICLE PLATE, 7 HOLE, RIGHT
008411321383663.5MM CLAVICLE PLATE, 5 HOLE, RIGHT
008411321383593.5MM CLAVICLE PLATE, 10 HOLE, LEFT
008411321383423.5MM CLAVICLE PLATE, 8 HOLE, LEFT
008411321383353.5MM CLAVICLE PLATE, 6 HOLE, LEFT
008411321383283.5MM CLAVICLE PLATE, 4 HOLE, LEFT
008411321383113.5MM CLAVICLE PLATE, 10 HOLE, RIGHT
008411321383043.5MM CLAVICLE PLATE, 8 HOLE, RIGHT
008411321382983.5MM CLAVICLE PLATE, 6 HOLE, RIGHT
008411321382813.5MM CLAVICLE PLATE, 4 HOLE, RIGHT
008411321382742.7MM CLAVICLE PLATE, 7 HOLE, LEFT
008411321382672.7MM CLAVICLE PLATE, 5 HOLE, LEFT
008411321382502.7MM CLAVICLE PLATE, 7 HOLE, RIGHT
008411321382432.7MM CLAVICLE PLATE, 5 HOLE, RIGHT
008411321382362.7MM CLAVICLE PLATE, 10 HOLE, LEFT
008411321382292.7MM CLAVICLE PLATE, 8 HOLE, LEFT
008411321382122.7MM CLAVICLE PLATE, 6 HOLE, LEFT
008411321382052.7MM CLAVICLE PLATE, 4 HOLE, LEFT
008411321381992.7MM CLAVICLE PLATE, 10 HOLE, RIGHT
008411321381822.7MM CLAVICLE PLATE, 8 HOLE, RIGHT
008411321381752.7MM CLAVICLE PLATE, 6 HOLE, RIGHT
008411321381682.7MM CLAVICLE PLATE, 4 HOLE, RIGHT
00841132137239PEDIFRAG SMALL AND MINI FRAGMENT SYSTEM (2.7/3.5/4.0) BOM
00841132130452PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
00841132130445PEDILOC FRAGMENT SYSTEM SCREW CADDY LID
00841132130438PEDILOC FRAGMENT SYSTEM SCREW CADDY
00841132130421PEDILOC FRAGMENT SYSTEM 2.7/3.5- 3.5 TRAY, SMALL
00841132130414PEDILOC FRAGMENT SYSTEM 2.7/3.5- 2.7 TRAY, SMALL
00841132130407PEDIFRAG TRAY, BASE
00841132138410CLAVICLE PLATE LID
00841132138403CLAVICLE PLATE TRAY
00841132122716T10 RETAINING DRIVER, SHORT
00841132122709T10 HEXALOBE DRIVER, SHORT
00841132122662T15 CANNULATED DRIVER, SHORT (DIA 1.25)
008411321226552.5 MM X 150 MM GUIDE WIRE, THREADED
00841132122648PLATE FIXATION PIN
00841132122631T15 HEXALOBE DRIVER, RETAINING
00841132122624T10 HEXALOBE DRIVER, RETAINING
00841132122617CANNULATED COUNTERSINK
008411321226003.5 MM DRILL BIT
008411321225942.7 MM DRILL BIT
008411321225872.0 MM CALIBRATED DRILL BIT
008411321225702.0 MM DRILL BIT
008411321383973.5MM CLAVICLE PLATE, 7 HOLE, LEFT
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