FDA.report

CARDINAL HEALTH

Primary DI
50197106988396
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN56MYLSA
Catalog number
SEN56MYLSA
Device description
MYRINGOTOMY PACK
Published
2025-04-25
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

Related Records

Product Codes

CodeName
OGSMyringotomy procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106988396PackageGS120In Commercial Distribution
10197106988398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710698839650197106988396
1019710698839810197106988398

GMDN Terms

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

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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50198956060447CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50198956021318CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-11
50197106824151CARDINAL HEALTHCardinal Health 200, LLCOGS2024-11-06
50197106783168CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-14
50197106795246CARDINAL HEALTHCardinal Health 200, LLCOGS2024-10-07
50197106766222CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-09
50197106739936CARDINAL HEALTHCardinal Health 200, LLCOGS2024-09-03
50197106757312CARDINAL HEALTHCardinal Health 200, LLCOGS2024-08-30
00840183527730BR Surgical, LLCBR Surgical, LLCOGS2024-08-09
00840183512941BR Surgical, LLCBR Surgical, LLCOGS2024-07-23
50197106708277CARDINAL HEALTHCardinal Health 200, LLCOGS2024-07-09
50197106616855CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106657803CARDINAL HEALTHCardinal Health 200, LLCOGS2024-05-16
50197106585939CARDINAL HEALTHCardinal Health 200, LLCOGS2024-03-21
50197106592753CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-29
50197106549252CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-27
50197106581566CARDINAL HEALTHCardinal Health 200, LLCOGS2024-02-23