FDA.report

CARDINAL HEALTH

Primary DI
50197106827329
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
22-0035A
Catalog number
22-0035A
Device description
CT BIOPSY TRAY SAFETY
Published
2025-01-06
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

Related Records

Product Codes

CodeName
OFGCT biopsy tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106827329PackageGS125In Commercial Distribution
10197106827321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710682732950197106827329
1019710682732110197106827321

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
50198956320718CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956364156CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956401479CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-10
50198956323009CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-02
50198956336610CARDINAL HEALTHCardinal Health 200, LLCOFG2026-02-20
00191072241696ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-02-02
50198956337266CARDINAL HEALTHCardinal Health 200, LLCOFG2026-01-26
00191072241559ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-01-14
50198956203936CARDINAL HEALTHCardinal Health 200, LLCOFG2025-12-17
50198956267846CARDINAL HEALTHCardinal Health 200, LLCOFG2025-11-17
00191072239570ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2025-09-29
50198956197440CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-22
50198956199987CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-19
50198956181364CARDINAL HEALTHCardinal Health 200, LLCOFG2025-08-27
40198459470760MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459474836MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459480233MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459481247MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459485092MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459450489MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453695MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453701MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453725MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453770MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453787MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453794MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453923MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459461690MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459462994MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459464738MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11