FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956516960
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA33MVAHD
Catalog number
SMA33MVAHD
Device description
MAJOR VAGINAL PACK AHN
Published
2026-07-20
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956516968PackageGS12In Commercial Distribution
10198956516960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651696850198956516968
1019895651696010198956516960

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17800A0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-07-21
10198956335486CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956412224CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956423169CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956458758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956467705CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956469983CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956499225CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956507364CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956507746CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956518575CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956521254CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956526259CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956526549CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956527034CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956527966CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956528550CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956529021CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956531901CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532311CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532458CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532472CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532625CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956533141CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956534391CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956535862CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956444768CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956453678CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956458055CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956518117CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16