Primary Device ID | 00840606169899 |
NIH Device Record Key | be9a3b8c-1da8-4208-9b65-c983dbfbb373 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KARMA MIS |
Version Model Number | 75600-000 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, 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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840606169899 [Primary] |
OJH | Orthopedic Tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
[00840606169899]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-14 |
Device Publish Date | 2022-02-04 |
00840606169974 | Awl Stylet |
00840606169936 | Karma® MIS Tray Base |
00840606169929 | Karma® MIS Tray Lower Level Insert |
00840606169912 | Karma® MIS Tray Top Level Insert |
00840606169905 | Karma® MIS Tray Lid |
00840606169899 | Karma® MIS Tray Assembly |
00840606167956 | Karma Tensioner |