FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594057969
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA29PPNS1
Catalog number
SMA29PPNS1
Device description
PREP PACK
Published
2021-04-29
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
OJWShave prep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJWShave Prep KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594057969PackageGS125In Commercial Distribution
10195594057961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559405796950195594057969
1019559405796110195594057961

GMDN Terms#

Term, Definition table
TermDefinition
Surgical patient preparation kitA collection of devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956251135CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
50197106861279CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
50197106823376CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
50197106816231CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
50197106731206CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
50197106552351CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
50197106662982CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
50197106704002CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
50197106441549CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
50195594775382CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
50195594450753CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
50195594432315CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
50195594159410CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
50195594291240CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
50195594132215CARDINAL HEALTHCardinal Health 200, LLCOJW2021-07-22
50195594112293CARDINAL HEALTHCardinal Health 200, LLCOJW2021-06-07
50195594087133CARDINAL HEALTHCardinal Health 200, LLCOJW2021-05-24
50195594017840CARDINAL HEALTHCardinal Health 200, LLCOJW2021-04-07
50888439986479CARDINAL HEALTHCardinal Health 200, LLCOJW2021-03-18
50195594915122CARDINAL HEALTHCardinal Health 200, LLCOJW2021-03-02
50888439562017CARDINAL HEALTHCardinal Health 200, LLCOJW2019-10-17
50888439221952CARDINAL HEALTHCardinal Health 200, LLCOJW2019-03-22
50888439266717CARDINAL HEALTHCardinal Health 200, LLCOJW2018-11-30
50888439261125CARDINAL HEALTHCardinal Health 200, LLCOJW2018-11-10
50888439097106CARDINAL HEALTHCardinal Health 200, LLCOJW2018-09-12
50888439077467CARDINAL HEALTHCardinal Health 200, LLCOJW2018-08-08
50887488974956CARDINAL HEALTHCardinal Health 200, LLCOJW2018-07-12
50887488971986CARDINAL HEALTHCardinal Health 200, LLCOJW2018-06-04
50887488931522CARDINAL HEALTHCardinal Health 200, LLCOJW2018-03-19
50887488926443CARDINAL HEALTHCardinal Health 200, LLCOJW2018-03-12