FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106523641
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4JGLWLA
Catalog number
SBA4JGLWLA
Device description
GENERAL LAPAROSCOPY PACK
Published
2024-01-24
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
FDAEnteroscope and accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDAEnteroscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106523641PackageGS14In Commercial Distribution
10197106523643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710652364150197106523641
1019710652364310197106523643

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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783012415Premier Jackson Improved Short Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYFDA2026-06-10
00860014745003FUJIFILM Stiffening Wire (SW-2000)Fujifilm Healthcare Americas CorporationFDA2025-12-18
04547410491715FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
04547410514056FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410491712FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
14547410514053FUJIFILMFUJIFILM CORPORATIONFDA2024-07-05
10197106523643CARDINAL HEALTHCardinal Health 200, LLCFDA2024-01-24
10197106447185CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
50197106447183CARDINAL HEALTHCardinal Health 200, LLCFDA2023-11-09
10860006600805AncoraAspero Medical, Inc.FDA2023-10-26
00847627004703CD138 + Cyclin D1BIOCARE MEDICAL LLCFDA2023-06-21
04547410467284FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
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04547410467260FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
14547410467281FUJIFILMFUJIFILM CORPORATIONFDA2023-02-06
04547410463439FUJIFILMFUJIFILM CORPORATIONFDA2022-01-30
04953170165801HANGER ADAPTER SETOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-17
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04953170165740STOPPEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165757WATER RESISTANT CAPOLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
04953170165764PROBE HANGEROLYMPUS MEDICAL SYSTEMS CORP.FDA2021-12-16
06934955960246Jade PTA Balloon Dilatation CatheterOrbusNeich Medical (ShenZhen) Co., Ltd.FDA2020-12-25
00052569143735HealthMart STRATEGIC SOURCING SERVICES LLCFDA2020-07-31
10052569143732HealthMart MCKESSON CORPORATIONFDA2020-07-31
00075289122811ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
70075289122810ProWorksTRANZONIC COMPANIES, THEFDA2020-04-02
04547410384536FUJIFILMFUJIFILM CORPORATIONFDA2019-07-04
00811503033316Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27
10811503033306Q UROLOGICAL PERSISTENT AGUAMEDICINA Q UROLOGICAL CORPORATIONFDA2019-03-27