| Primary Device ID | 00853190008932 |
| NIH Device Record Key | bd789977-cdb2-4d81-a072-daf38c12a8df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Manubrium Plate 10 Holes, Implant Positioner |
| Version Model Number | 215.110.10 |
| Company DUNS | 063554875 |
| Company Name | JACE MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 00853190008932 [Primary] |
| HRS | Plate, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
[00853190008932]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-18 |
| Device Publish Date | 2021-02-10 |
| 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 |