FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439759691
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN11MPMM3
Catalog number
SEN11MPMM3
Device description
MYRINGOTOMY PACK
Published
2020-02-19
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
OGSMyringotomy procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGSMyringotomy Procedure KitEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439759691PackageGS110In Commercial Distribution
10888439759693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843975969150888439759691
1088843975969310888439759693

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical 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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956374195CARDINAL HEALTHCardinal Health 200, LLCOGS2026-04-14
10198956403369CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
50198956403367CARDINAL HEALTHCardinal Health 200, LLCOGS2026-03-19
10198956358874CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956369054CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956358872CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
50198956369052CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-23
10198956317628CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
50198956317626CARDINAL HEALTHCardinal Health 200, LLCOGS2026-02-13
00191072241351ACSAMERICAN CONTRACT SYSTEMS, INC.OGS2026-01-06
10198956261679CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
50198956261677CARDINAL HEALTHCardinal Health 200, LLCOGS2025-12-17
10198956223479CARDINAL HEALTHCardinal Health 200, LLCOGS2025-10-23
10198956180819CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
50198956180817CARDINAL HEALTHCardinal Health 200, LLCOGS2025-08-27
10198956132733CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
50198956132731CARDINAL HEALTHCardinal Health 200, LLCOGS2025-07-31
10198956111936CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
50198956111934CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-30
10198956117242CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
50198956117240CARDINAL HEALTHCardinal Health 200, LLCOGS2025-06-16
10197106858844CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
50197106858842CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-29
10198956079984CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
50198956079982CARDINAL HEALTHCardinal Health 200, LLCOGS2025-05-21
10198956060364CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
50198956060362CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-29
10197106988398CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
10198956060449CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25
50197106988396CARDINAL HEALTHCardinal Health 200, LLCOGS2025-04-25