Primary Device ID | 00850058951010 |
NIH Device Record Key | a2406070-70a5-4e40-a257-bde99da71135 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Amtouch Etchant Gel |
Version Model Number | Jumbo Refill 25ml |
Catalog Number | AMETCHJUMBO |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Special Storage Condition, Specify | Between 0 and 0 *Special Storage |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850058951010 [Primary] |
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-23 |
Device Publish Date | 2024-05-15 |
00850058951010 | Amtouch Etchant Gel 37%, Medium Viscosity, Jumbo Refill, 25ml (2x Syringes) |
00850058951003 | Amtouch Etchant Gel 37%, Medium Viscosity, Jumbo Kit, 25ml (1x Syringes, 2x Tips) |
00850048528994 | Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (24x Syringes) |
00850048528987 | Amtouch Etchant Gel 37%, Medium Viscosity, 1.2ml (4x Syringes, 4x Tips) |