Primary Device ID | 00850007728168 |
NIH Device Record Key | cc996c56-3b35-4c1f-8ed6-9d6246b6b99a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Water Flosser |
Version Model Number | 100-0366 |
Company DUNS | 054012763 |
Company Name | ACCESS DENTAL LAB, 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 | false |
Lot Batch | false |
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 | false |
OTC Over-The-Counter | true |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com | |
Phone | 901-361-0576 |
joe.miller@accessdentallab.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850007728168 [Primary] |
EFS | Unit, Oral Irrigation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-08-27 |
Device Publish Date | 2019-08-19 |
00850007728427 - SmileDirectClub Retainer | 2023-12-08 SmileDirectClub Retainers consist of a clear plastic removable orthodontic appliance which are intended to hold the teeth in the |
00850007728243 - SDC impression material (Zest) | 2023-02-27 impression material used to create dental impressions |
00850007728250 - SDC-impression material (Kulzer) | 2023-02-27 putty material used to create dental impressions. |
00850007728342 - Smile stretcher-purple bag | 2023-02-27 Smile stretcher in foil purple pouch |
00850007728366 - Impression Tray XSM | 2023-02-27 Impression Tray Extra Small |
00850007728373 - IMPRESSION TRAY SM | 2023-02-27 IMPRESSION TRAY SMALL SIZE |
00850007728380 - IMPRESSION TRAY MED | 2023-02-27 IMPRESSION TRAY MEDIUM SIZE |
00850007728397 - IMPRESSION TRAY LRG | 2023-02-27 IMPRESSION TRAY LARGE SIZE |