FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00885425933559
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA21EDEUA
Catalog number
SBA21EDEUA
Device description
STERILE ENDOSCOPY PACK
Published
2015-08-14
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
NWUKit, introducer, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425933554PackageGS110In Commercial Distribution
00885425933559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088542593355450885425933554
00885425933559008854259335598854259335590885425933559

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964153877Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153921Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964153976Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154089Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
00677964154096Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-07-20
10198956366251CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956456952CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956469761CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956508415CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956509542CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956515666CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956529823CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956531260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532304CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532618CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956532762CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-20
10198956495067CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956502789CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956518056CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956527232CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956528963CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-16
10198956457768CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956465749CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956486065CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956491939CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956508286CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956512382CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956526686CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956527621CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09
10198956528260CARDINAL HEALTHCardinal Health 200, LLCNWU2026-07-09