Primary Device ID | 00766054001256 |
NIH Device Record Key | 848b8839-3db5-4efe-a466-8920a85cf12d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | C-Mor Dental Mirror Handle |
Version Model Number | 5001-HS |
Catalog Number | 5001-HS |
Company DUNS | 101147171 |
Company Name | ESSENTIAL DENTAL SYSTEMS, INC. |
Device Count | 1 |
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 | 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(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com | |
Phone | +1(201)487-9090 |
udi@edsdental.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00766054001256 [Primary] |
EJB | HANDLE, INSTRUMENT, DENTAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
[00766054001256]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-27 |
Device Publish Date | 2020-07-17 |
00766054002949 - BIOSEAL | 2024-11-08 Bioceramic Endodontic Sealer |
00766054002970 - BIOSEAL | 2024-11-08 EndoTips |
00766054002901 - Bio-LCB | 2022-11-07 Light Cured Base and Liner Syrinageable |
00766054002918 - Bio-LCB | 2022-11-07 Light Cured Base and Liner Syrinageable |
00766054002925 - Bio-LCB | 2022-11-07 50 Light Cured Base and Liner Syringe Tips |
00766054002932 - Bio-LCB | 2022-11-07 Light Cured Base and Liner Syrinageable |
00766054000617 - Tango-Endo | 2020-07-27 Tango-Endo Intro Kit 25mm |
00766054000624 - Tango-Endo | 2020-07-27 Tango-Endo Intro Kit 21mm |