Flexible Pusher Tip and Set Screw

GUDID 00858406007600

SURGENTEC, LLC

Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable

Primary Device ID	00858406007600
NIH Device Record Key	912c6952-3824-4ad3-afb6-06c53dba47ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	Flexible Pusher Tip and Set Screw
Version Model Number	3D-T01-07
Company DUNS	004095409
Company Name	SURGENTEC, LLC
Device Count	1
DM Exempt	false
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 Identifiers

Device Issuing Agency	Device ID
GS1	00858406007600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201900

FDA Product Code

HTR

Rasp