FDA.report

CARDINAL HEALTH

Primary DI
10198956468412
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN33PBAHD
Catalog number
SAN33PBAHD
Device description
PROC BRACHY THERAPY PACK WPH
Published
2026-05-25
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
OINProstate seeding kit

Product Code Classifications

CodeDeviceSpecialtyClass
OINProstate Seeding KitRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50198956468410PackageGS12In Commercial Distribution
10198956468412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019895646841050198956468410
1019895646841210198956468412

GMDN Terms

TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

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

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10192253013016Argyle888875001888887500182022-10-26
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10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
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10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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