FDA.report

CARDINAL HEALTH

Primary DI
50198956087482
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA29DDFGO
Catalog number
SMA29DDFGO
Device description
D AND C PACK
Published
2025-06-10
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
PKFD and C tray

Product Code Classifications

CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50198956087482PackageGS14In Commercial Distribution
10198956087484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019895608748250198956087482
1019895608748410198956087484

GMDN Terms

TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

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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10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
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