FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106623497
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03-0209A
Catalog number
03-0209A
Device description
CENTRAL LINE DRESSING KIT
Published
2024-04-29
Public version status
New
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
OXAMesh, surgical, non-absorbable, thoracic, chest wall reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall ReconstructionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106623495PackageGS188In Commercial Distribution
10197106623497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662349550197106623495
1019710662349710197106623497

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
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
10198956099838CARDINAL HEALTHCardinal Health 200, LLCOXA2025-06-05
50198956099836CARDINAL HEALTHCardinal Health 200, LLCOXA2025-06-05
10197106803066CARDINAL HEALTHCardinal Health 200, LLCOXA2024-12-04
50197106803064CARDINAL HEALTHCardinal Health 200, LLCOXA2024-12-04
50197106623495CARDINAL HEALTHCardinal Health 200, LLCOXA2024-04-29
10197106575468CARDINAL HEALTHCardinal Health 200, LLCOXA2024-03-15
50197106575466CARDINAL HEALTHCardinal Health 200, LLCOXA2024-03-15
10197106401095CARDINAL HEALTHCardinal Health 200, LLCOXA2023-09-13
50197106401093CARDINAL HEALTHCardinal Health 200, LLCOXA2023-09-13
10195594693763CARDINAL HEALTHCardinal Health 200, LLCOXA2022-07-26
50195594693761CARDINAL HEALTHCardinal Health 200, LLCOXA2022-07-26
00650862311051C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311068C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311075C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311266C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311273C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311280C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311310C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311334C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311341C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311358C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311365C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311372C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311389C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311402C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311426C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311433C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24
00650862311440C-QUR MOSAICAtrium Medical CorporationOXA2015-09-24