Primary Device ID | 00192029017005 |
NIH Device Record Key | 60a48890-3288-4911-a157-ee907e3f5fb5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SOLDERABLE STOP |
Version Model Number | 226-008 |
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 | 00192029017005 [Primary] |
ECN | CLAMP, WIRE, 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 | 2021-02-23 |
Device Publish Date | 2021-02-15 |
00192029050538 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL CEN Torque +12, Tip +5 |
00192029050545 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR CEN Torque +12, Tip +5 |
00192029050552 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL LAT Torque +8, Tip +9 |
00192029050569 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR LAT Torque +8, Tip +9 |
00192029050576 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UL CUS Torque -4, Tip +11 |
00192029050583 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UR CUS Torque -4, Tip +11 |
00192029050590 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UP BI CCW Torque -7, Tip 0 |
00192029050606 - Tip-Edge PLUS Stainless Steel Brackets | 2025-02-12 UP BI CW Torque -7, Tip 0 |