FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439015331
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
13-5065D
Catalog number
13-5065D
Device description
SPINAL INJECTION TRAY
Published
2018-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439015339PackageGS130In Commercial Distribution
10888439015331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843901533950888439015339
1088843901533110888439015331

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956486232CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-05
10198956454705CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-03
10198956405004CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-01
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594520434CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-09-02
10195594516130CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-07-21
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594516338CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594530839CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594509859CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-14
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519902CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519919CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26
10195594544065CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-21
10195594456221CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-15
10195594487225CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-11
10195594500009CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594520601CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594527860CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594461188CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-08
10195594503772CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594520533CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07
10195594540340CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07