| Primary Device ID | 00192029038796 | 
| NIH Device Record Key | b53fe10c-dc9a-4bfd-9df4-2bf0ca11b676 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | E-Chain | 
| Version Model Number | 390-160 | 
| 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 | 00192029038796 [Primary] | 
| ECI | BAND, ELASTIC, 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 | 
Mark Image Registration | Serial  | Company  Trademark Application Date  | 
|---|---|
![]() E-CHAIN  78090107  2654537 Live/Registered  | 
        IGUS GMBH  2001-10-25  | 
![]() E-CHAIN  76467388  2896214 Live/Registered  | 
        LABORATORY CORPORATION OF AMERICA HOLDINGS  2002-11-15  | 
![]() E-CHAIN  75731228  not registered Dead/Abandoned  | 
        Hewlett-Packard Company  1999-06-17  | 
![]() E-CHAIN  75684389  not registered Dead/Abandoned  | 
        U.S. Tsubaki, Inc.  1999-04-15  | 
![]() E-CHAIN  75433063  not registered Dead/Abandoned  | 
        DAMPSKIBSSELSKABET AF 1912, AKTIESELSKAB  1998-02-12  | 
![]() E-CHAIN  75433063  not registered Dead/Abandoned  | 
        AKTIESELSKABET DAMPSKIBSSELSKABET SVENDBORG  1998-02-12  |