FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594127518
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE54LMMT2
Catalog number
SNE54LMMT2
Device description
LAMINECTOMY PACK MOUNTAIN VIST
Published
2021-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594127518PackageGS11In Commercial Distribution
10195594127510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559412751850195594127518
1019559412751010195594127510

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537633HalyardAVID MEDICAL, INC.OJG2026-09-19
10809160537725HalyardAVID MEDICAL, INC.OJG2026-09-19
10809160536445HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537046HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537305HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537336HalyardAVID MEDICAL, INC.OJG2026-09-18
10809160537374HalyardMEDICAL ACTION INDUSTRIES INC.OJG2026-09-18
10198956475113CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956486362CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956491304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956518667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956554948CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956555389CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559691CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956559974CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956560895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562509CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562707CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956562790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563186CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956563575CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569126CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956569751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570092CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570139CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570313CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956570559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571686CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571716CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04
10198956571761CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-04