EdgeSequel Utopia ES300625SE

GUDID 10810047645549

Rotary/reciprocating endodontic file/rasp, reusable

Primary Device ID	10810047645549
NIH Device Record Key	701d0457-284c-42a4-b90b-bf550993c379
Commercial Distribution Status	In Commercial Distribution
Brand Name	EdgeSequel Utopia
Version Model Number	ES300625SE
Catalog Number	ES300625SE
Company DUNS	061317427
Company Name	US ENDODONTICS, LLC
Device Count	6
DM Exempt	true
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	true
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	00810047645542 [Primary]
GS1	10810047645549 [Unit of Use]

EKS	FILE, PULP CANAL, ENDODONTIC

Steralize Prior To Use	false
Device Is Sterile	true

10810047645648	Sterile Endodontic Rotary File
10810047645631	Sterile Endodontic Rotary File
10810047645624	Sterile Endodontic Rotary File
10810047645617	Sterile Endodontic Rotary File
10810047645600	Sterile Endodontic Rotary File
10810047645594	Sterile Endodontic Rotary File
10810047645587	Sterile Endodontic Rotary File
10810047645570	Sterile Endodontic Rotary File
10810047645563	Sterile Endodontic Rotary File
10810047645556	Sterile Endodontic Rotary File
10810047645549	Sterile Endodontic Rotary File
10810047645532	Sterile Endodontic Rotary File
10810047645525	Sterile Endodontic Rotary File
10810047645518	Sterile Endodontic Rotary File
10810047645501	Sterile Endodontic Rotary File
10810047645495	Sterile Endodontic Rotary File
10810047645488	Sterile Endodontic Rotary File
10810047645471	Sterile Endodontic Rotary File
10810047645464	Sterile Endodontic Rotary File
10810047645457	Sterile Endodontic Rotary File
10810047645440	Sterile Endodontic Rotary File
10810047645433	Sterile Endodontic Rotary File
10810047645426	Sterile Endodontic Rotary File
10810047645419	Sterile Endodontic Rotary File
10810047645402	Sterile Endodontic Rotary File
10810047645396	Sterile Endodontic Rotary File
10810047645389	Sterile Endodontic Rotary File
10810047645372	Sterile Endodontic Rotary File
10810047645365	Sterile Endodontic Rotary File
10810047645358	Sterile Endodontic Rotary File