FDA.report

CARDINAL HEALTH

Primary DI
50195594504685
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-3447F
Catalog number
34-3447F
Device description
SPINE TRAY
Published
2022-01-11
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
OFUSpinal anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594504685PackageGS124In Commercial Distribution
10195594504687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559450468550195594504685
1019559450468710195594504687

GMDN Terms

TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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

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10192253013016Argyle888875001888887500182022-10-26
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10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
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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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04046955672370Design Options®B. BRAUN MEDICAL INC.OFU2026-05-24
50198956359329CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956406801CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956421170CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956393347CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
50198956364620CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
50198956238730CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956343601CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956270747CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
50198956266511CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
04046955672028Design Options®B. BRAUN MEDICAL INC.OFU2025-12-22
04046961012641Design Options®B. BRAUN MEDICAL INC.OFU2025-08-31
50198956169591CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
50198956133691CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
50198956099638CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
50198956080650CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
04046955672004Design Options®B. BRAUN MEDICAL INC.OFU2025-04-27
50197106924134CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
50198956009651CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
50198956007244CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
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50197106955466CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11
50197106839353CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
50197106938513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28
50197106951987CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-21
50197106882953CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-03
50197106887279CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106907328CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106878611CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-21
50197106879694CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-06