FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594436450
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA13CCMGE
Catalog number
SBA13CCMGE
Device description
CAMERA COVER PACK
Published
2021-12-02
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
KQMCAMERA, SURGICAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594436450PackageGS18In Commercial Distribution
10195594436452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559443645050195594436450
1019559443645210195594436452

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

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
00860015454744RocotoRocoto Inc.KQM2026-02-26
00860015454751RocotoRocoto Inc.KQM2026-02-26
00818089022437RadianceNds Surgical Imaging LLCKQM2026-02-10
08800025400692EZ SHOT SEGOOD DOCTORS CO., LTD.KQM2026-01-15
05415334050020BarcoBarco NVKQM2025-12-22
05415334050013BarcoBarco NVKQM2025-12-01
00819761023032Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-25
00819761023049Optik ViewLINDEN GROUP CORPORATION, THEKQM2025-11-24
00860012447107EclipseInnovations Lightx IncKQM2025-11-12
00724995245061HexaVueBLACK DIAMOND VIDEO, INC.KQM2025-10-17
00810000890712FSNFORESEESON CUSTOM DISPLAYS, INC.KQM2025-09-15
04548736170698SONYSONY CORPORATIONKQM2025-09-12
04548736170711SONYSONY CORPORATIONKQM2025-09-12
07613327661194In-Light CameraSTRYKER COMMUNICATIONS INC.KQM2025-08-27
B17731260532L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260532Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-23
B17731260455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
B17731260455Z0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALKQM2025-07-21
04995047069867CuratOREIZO CORPORATIONKQM2025-07-18
04995047070320CuratOREIZO CORPORATIONKQM2025-07-18
00840183530402BR Surgical, LLCBR Surgical, LLCKQM2025-07-16
20618125114669SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170728SONYSONY CORPORATIONKQM2025-07-08
04548736170742SONYSONY CORPORATIONKQM2025-07-08
06972039971085MOPTIMShenzhen CERTAINN Technology Co., Ltd.KQM2025-06-30
00860014100642AmimonRocoto Inc.KQM2025-06-24
00860014100659AmimonRocoto Inc.KQM2025-06-24
05415334051133SterisBarco NVKQM2025-06-05
04548736167117SONYSONY CORPORATIONKQM2025-05-30
04548736167124SONYSONY CORPORATIONKQM2025-05-30