Syndesmosis Repair Implantation System AB-3300

GUDID 10854629006861

Fluted surgical drill bit, single-use

Primary Device ID	10854629006861
NIH Device Record Key	e979e83b-df64-4d21-bbaa-4f1db49fa263
Commercial Distribution Status	In Commercial Distribution
Brand Name	Syndesmosis Repair Implantation System
Version Model Number	AB-3300
Catalog Number	AB-3300
Company DUNS	079471560
Company Name	DUNAMIS MEDICAL, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	true
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	10854629006861 [Primary]

HTW	Bit, Drill

Steralize Prior To Use	false
Device Is Sterile	true

00854629006703	Syndesmosis Repair Implantation System
00854629006741	Syndesmosis Repair Implantation System For use with AB-3000
10854629006861	3.3mm Syndesmosis Repair Implantation System For use with AB-3000