FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106175581
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21MPPS1
Catalog number
SBA21MPPS1
Device description
MELOPLASTY TRAY
Published
2023-03-23
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
LAAHigh pressure liquid chromatography, benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAAHigh Pressure Liquid Chromatography, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106175581PackageGS13In Commercial Distribution
10197106175583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710617558150197106175581
1019710617558310197106175583

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.

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106831021CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
50197106831029CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
10197106819371CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
50197106819379CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
10197106873083CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
50197106873081CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
10197106782743CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
50197106782741CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
10197106782132CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106792957CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106782130CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106792955CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106743584CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-09
50197106743582CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-09
10197106616956CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
50197106616954CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
10197106669815CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
50197106669813CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
10197106668979CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
50197106668977CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
10197106652381CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
50197106652389CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
10197106600436CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106650110CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106600434CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106650118CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106577974CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
10197106621868CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106577972CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106621866CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19