FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594890078
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
08A8060E
Catalog number
08A8060E
Device description
LACERATION TRAY
Published
2023-02-16
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
OJVSingle use instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJVSingle Use Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594890078PackageGS148In Commercial Distribution
10195594890070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559489007850195594890078
1019559489007010195594890070

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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 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
10198956340435CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
10198956460164CARDINAL HEALTHCardinal Health 200, LLCOJV2026-05-25
50198956350289CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956413991CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-24
50198956418101CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-23
50198956326437CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-19
50198956350920CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-16
50198956357059CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956363333CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956387872CARDINAL HEALTHCardinal Health 200, LLCOJV2026-03-02
50198956334067CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956375756CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-23
50198956344813CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-13
50198956020250CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956293791CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-09
50198956314557CARDINAL HEALTHCardinal Health 200, LLCOJV2026-02-02
50198956258790CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
50198956316025CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-30
00884450306857Performa®Merit Medical Systems, Inc.OJV2026-01-29
50198956285895CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-23
50198956263008CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956300284CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-22
50198956286915CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956300406CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-16
50198956203011CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301212CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-15
50198956301823CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-13
50198956303452CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-07
50198956292831CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05
50198956305487CARDINAL HEALTHCardinal Health 200, LLCOJV2026-01-05