Primary Device ID | 00850058951256 |
NIH Device Record Key | 5bb25da0-06f1-4741-afa9-ed1e5dc886af |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Amtouch Orthodontic Kit |
Version Model Number | Orthodontic Kit (8pc) |
Catalog Number | AMOHK-AD |
Company DUNS | 180611519 |
Company Name | AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC. |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850058951256 [Primary] |
EFW | Toothbrush, Manual |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-25 |
Device Publish Date | 2024-10-17 |
00850058951232 - Amtouch Toothbrushes | 2024-10-25 Disposable Toothbrushes - Prepasted - Adult (100/Box) |
00850058951249 - Amtouch Dental Kit | 2024-10-25 Dental Hygiene Kit (5pc) |
00850058951256 - Amtouch Orthodontic Kit | 2024-10-25Orthodontic Kit (8pc) |
00850058951256 - Amtouch Orthodontic Kit | 2024-10-25 Orthodontic Kit (8pc) |
00850058951355 - Amtouch Orthodontic Flosspicks | 2024-10-25 Orthodontic Flosspicks - White (30/pk) |
00850048528864 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Metal Core/White Tube - White (250/Bag) |
00850048528901 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Color Core/Clear Tube - Assorted (250/Bag) |
00850048528918 - Amtouch Air/Water Syringe Tips | 2024-10-16 Air/Water Syringe Tips - Color Core/Clear Tube - Assorted (1000/Bag) |
00850058951263 - Amtouch Intraoral Tips | 2024-10-16 Intraoral Tips - Yellow (100/Bag) |