FDA.reportPublic FDA data

KARMA MIS

Primary DI
00840606169929
Brand
KARMA MIS
Company
SPINAL ELEMENTS, INC.
Model
75600-000-03
Device description
Karma® MIS Tray Lower Level Insert
Published
2022-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606169929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606169929008406061699298406061699290840606169929

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606158213KARMA75310-0002020-03-03
00840466901196Primus66012-095-0302026-03-27
00840466901202Primus66012-095-0352026-03-27
00840466901219Primus66012-105-0302026-03-27
00840466901226Primus66012-105-0352026-03-27
00840466901233Primus66012-105-0402026-03-27
00840466901240Primus66012-105-0452026-03-27
00840466901257Primus66012-105-0502026-03-27
00840466901264Primus66012-105-0552026-03-27
00840466901271Primus66023-045-0302026-03-27
00840466901288Primus66023-045-0352026-03-27
00840466901295Primus66023-045-0402026-03-27
00840466901301Primus66023-045-0452026-03-27
00840466901318Primus66023-045-0502026-03-27
00840466901325Primus66023-055-0252026-03-27
00840466901332Primus66023-055-0302026-03-27
00840466901349Primus66023-055-0352026-03-27
00840466901356Primus66023-055-0402026-03-27
00840466901363Primus66023-055-0452026-03-27
00840466901370Primus66023-055-0502026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
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10198956359963CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956364905CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956382657CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956393141CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956395275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956404656CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956415171CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956422971CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956430716CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956439481CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956440814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956446038CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956446045CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956452930CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956453173CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454453CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956454866CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956458710CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956463912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956465633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956471856CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956472792CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956473140CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956475250CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476004CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05
10198956476257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-05