FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956460676
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA11PLFHC
Catalog number
SMA11PLFHC
Device description
PELVISCOPY PACK
Published
2026-07-27
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
50198956460674PackageGS13In Commercial Distribution
10198956460676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646067450198956460674
1019895646067610198956460676

GMDN Terms#

Term, Definition table
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.

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956196261CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956385573CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956392410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956446632CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956448186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956469242CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956475182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956485297CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956497726CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956502727CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956505926CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956507173CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513044CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513983CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956516267CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956517301CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956521360CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956522602CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956523494CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956532816CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956534537CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956535213CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956535565CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956535923CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956536081CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956537590CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
B098AMS190570Aligned Medical SolutionsAligned Medical SolutionsOHD2026-07-25
B098AMS17800A0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-07-21
10198956335486CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956412224CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20