PediFlex Advanced 00-1001-0115

GUDID 00841132145562

Femur nail, sterile

Primary Device ID	00841132145562
NIH Device Record Key	af5224bb-8e6c-4aaa-9fc8-fd017e74469c
Commercial Distribution Status	In Commercial Distribution
Brand Name	PediFlex Advanced
Version Model Number	00-1001-0115
Catalog Number	00-1001-0115
Company DUNS	796416191
Company Name	ORTHOPEDIATRICS CORP.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00841132145562 [Primary]

HTY	PIN, FIXATION, SMOOTH

Steralize Prior To Use	false
Device Is Sterile	false

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