FDA.reportPublic FDA data

KARMA MIS

Primary DI
00840606169905
Brand
KARMA MIS
Company
SPINAL ELEMENTS, INC.
Model
75600-000-01
Device description
Karma® MIS Tray Lid
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
00840606169905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606169905008406061699058406061699050840606169905

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
10198956218611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956332096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956343139CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956395107CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956433984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956434677CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956435636CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956437883CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956440326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956446076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956453661CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956455429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956460720CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956461888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956464759CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956481565CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482425CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483279CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483835CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484764CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484887CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956487192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956488175CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08