Primary Device ID | H668166210 |
NIH Device Record Key | 8effa076-711a-4f40-a5e8-d8987f994602 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cora-Caine |
Version Model Number | 16621 |
Catalog Number | 16621 |
Company DUNS | 073503117 |
Company Name | Keystone Industries |
Device Count | 36 |
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 | true |
Single Use | true |
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 |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com | |
Phone | +1(800)333-3131 |
tschwear@keystoneind.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H668166210 [Unit of Use] |
HIBCC | H668166211 [Primary] |
KOP | ADHESIVE, DENTURE, KARAYA |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-08 |
Device Publish Date | 2022-11-30 |
H66842000100 - KeyPrint | 2024-07-03 3D Intro Kit |
H6683524850 - Omni | 2024-07-01 Prophy Paste Bubble Gum Medium Box/200 |
H6683524860 - Omni | 2024-07-01 Prophy Paste Bubble Gum Coarse Box/200 |
H6683524870 - Omni | 2024-07-01 Prophy Paste Assorted Medium Box/200 |
H6683524880 - Omni | 2024-07-01 Prophy Paste Assorted Coarse Box/200 |
H66841101412 - KeyPrint | 2023-10-03 KeySplint Hard Pink 1kg |
H66842201512 - KeyPrint | 2023-10-03 KeySplint Soft Pink 1kg |
H66896346001 - Procure | 2023-06-27 Procure Denture Reline Hard & Soft Intro Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CORA-CAINE 72024125 0663034 Live/Registered |
CORALITE DENTAL PRODUCTS 1957-02-11 |