OrthoPediatrics ACL Reconstruction System 10-1008-1090

GUDID 00841132122174

Ligament bone anchor

Primary Device ID	00841132122174
NIH Device Record Key	ef5a140b-9043-403e-8dcb-452881b25f40
Commercial Distribution Status	In Commercial Distribution
Brand Name	OrthoPediatrics ACL Reconstruction System
Version Model Number	10-1008-1090
Catalog Number	10-1008-1090
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	false
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

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

Device Issuing Agency	Device ID
GS1	00841132122174 [Primary]

MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Steralize Prior To Use	true
Device Is Sterile	true

[00841132122174]

Radiation Sterilization