FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956488229
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA63OPST6
Catalog number
SMA63OPST6
Device description
VAGINAL DELIVERY PACK
Published
2026-06-01
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956488227PackageGS16In Commercial Distribution
10198956488229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895648822750198956488227
1019895648822910198956488229

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522165HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522257HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522141HalyardAVID MEDICAL, INC.OKV2026-05-29
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489428605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489430660Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489431643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489445053Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489447002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454505Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455076Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489455663Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489420708Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-04-30