| Primary Device ID | 00853190008307 | 
| NIH Device Record Key | d5598ebf-d747-4fe9-9df9-136b7460a7a2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Double Wire Twister | 
| Version Model Number | 232.001.00 | 
| Company DUNS | 063554875 | 
| Company Name | JACE MEDICAL, LLC | 
| 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 | false | 
| 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 | 00853190008307 [Primary] | 
| HXS | Twister, Wire | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
[00853190008307]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-12-29 | 
| Device Publish Date | 2021-12-21 | 
| 00853190008895 - Universal Plate Cutter | 2024-02-23 | 
| 00850051329014 - Sternalock EZ | 2023-11-28 Y Plate, 12 Holes, Narrow | 
| 00850051329021 - Sternalock EZ | 2023-11-28 Y Plate, 12 Holes, Wide | 
| 00853190008352 - Sternalock EZ | 2023-11-28 V Plate, 8 Holes | 
| 00853190008512 - Sternalock EZ | 2023-11-28 V Plate, 4 Holes | 
| 00853190008529 - Sternalock EZ | 2023-11-28 H Plate, 6 Holes | 
| 00853190008635 - Sternalock EZ | 2023-11-28 Box Plate, 4 Holes | 
| 00853190008642 - Sternalock EZ | 2023-11-28 O Plate, 6 Hole |