Primary Device ID | 00853190008703 |
NIH Device Record Key | df1b2df4-f516-44f7-be92-58cf64b33716 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XL Plate Cutter |
Version Model Number | 215.010.45 |
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 | 00853190008703 [Primary] |
HXZ | Cutter, Wire |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
[00853190008703]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-11 |
Device Publish Date | 2019-09-03 |
00853190008895 - Universal Plate Cutter | 2024-02-23 |
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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 |