KARMA MIS

GUDID 00840606169899

Karma® MIS Tray Assembly

SPINAL ELEMENTS, INC.

Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00840606169899
NIH Device Record Keybe9a3b8c-1da8-4208-9b65-c983dbfbb373
Commercial Distribution StatusIn Commercial Distribution
Brand NameKARMA MIS
Version Model Number75600-000
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606169899 [Primary]

FDA Product Code

OJHOrthopedic Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-14
Device Publish Date2022-02-04

On-Brand Devices [KARMA MIS]

00840606169974Awl Stylet
00840606169936Karma® MIS Tray Base
00840606169929Karma® MIS Tray Lower Level Insert
00840606169912Karma® MIS Tray Top Level Insert
00840606169905Karma® MIS Tray Lid
00840606169899Karma® MIS Tray Assembly
00840606167956Karma Tensioner

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