Primary Device ID | 00766054002857 |
NIH Device Record Key | aed41cb7-d542-4955-8384-26ab8f3bc1fc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Endo CSV |
Version Model Number | 5100-LED |
Catalog Number | 5100-LED |
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 | false |
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 | 00766054002857 [Primary] |
EBA | LIGHT, SURGICAL HEADLIGHT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
Moist Heat or Steam Sterilization
[00766054002857]
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 |
00766054002857 | Endo CSV LED Light |
00766054002840 | Endo CSV Replacement Head |
00766054002734 | Endo CSV Hand Piece with 25 mm Instruments |
00766054002727 | Endo CSV Hand Piece with 21 mm Instruments |
00766054002710 | Endo CSV Hand Piece |