FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106857531
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANRPPFBAA
Catalog number
SANRPPFBAA
Device description
IR PACK FLINT
Published
2025-03-04
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106857531PackageGS13In Commercial Distribution
10197106857533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710685753150197106857531
1019710685753310197106857533

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
00191072242037ACSAMERICAN CONTRACT SYSTEMS, INC.OIP2026-03-24
50198956418415CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-24
50198956141207CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956338461CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956415209CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-23
50198956329537CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956341997CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956381238CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956425802CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-16
50198956318166CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956388183CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956395341CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-10
50198956408430CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-06
50198956351392CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-03
50198956331431CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956372601CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956373868CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956377279CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956383973CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956386691CARDINAL HEALTHCardinal Health 200, LLCOIP2026-03-02
50198956335613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956368710CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-23
50198956297843CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-20
50198956322613CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956330847CARDINAL HEALTHCardinal Health 200, LLCOIP2026-02-09
50198956167566CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956324075CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956325935CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956345001CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-30
50198956334920CARDINAL HEALTHCardinal Health 200, LLCOIP2026-01-29