Primary Device ID | 00192029015612 |
NIH Device Record Key | b0d36481-c076-41f4-a39c-d0d3ed261af0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ultra Low Profile Molar Tube |
Version Model Number | 391-738 |
Company DUNS | 005432299 |
Company Name | TP ORTHODONTICS 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 | 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00192029015612 [Primary] |
DZD | TUBE, ORTHODONTIC |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-23 |
Device Publish Date | 2021-03-15 |
00192029050491 - Cuspid Laminated Mesh | 2024-01-05 MISC. BRACKETS |
00192029043264 - Foam Pellets | 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin |
00192029043271 - Bonding Accessories | 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin |
00192029043288 - Bonding Accessories | 2023-10-13 ADHESIVE, BRACKET-Tooth Conditioner, Resin |
00192029017494 - Tip-Edge SL PLUS Stainless Steel Brackets | 2022-10-25 SL PLUS NON EXT 22 KIT |
00192029017500 - Tip-Edge SL PLUS Stainless Steel Brackets | 2022-10-25 SL PLUS NON EXT 22 KIT OR |
00192029017517 - Tip-Edge SL PLUS Stainless Steel Brackets | 2022-10-25 SL TE PLUS UL CEN 22 |
00192029017524 - Tip-Edge SL PLUS Stainless Steel Brackets | 2022-10-25 SL TE PLUS UR CEN 22 |