Primary Device ID | 00766054002994 |
NIH Device Record Key | 53cebd6c-f2b3-469d-b021-359a0fb5dd3a |
Commercial Distribution Discontinuation | 2025-04-04 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Turbo-CR |
Version Model Number | 1100-00 |
Catalog Number | 1100-00 |
Company DUNS | 101147171 |
Company Name | ESSENTIAL DENTAL SYSTEMS, INC. |
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 | false |
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 |
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 | 00766054002994 [Primary] |
ELC | Scaler, ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-14 |
Device Publish Date | 2025-04-04 |
00766054003007 | Disposable Fluoride Trays |
00766054002994 | Calculus Softener |
00766054002987 | Mixing Tips |