FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106583982
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
MAT6999591
Catalog number
MAT6999591
Device description
KIT, LOS GATOS MATERNITY
Published
2024-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRAHearing aid, tactile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRAHearing Aid, TactileUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106583980PackageGS15In Commercial Distribution
10197106583982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710658398050197106583980
1019710658398210197106583982

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101357CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10198956102637CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956101355CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956102635CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10197106833261CARDINAL HEALTHCardinal Health 200, LLCLRA2024-12-10
10197106767566CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
50197106767564CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
10197106754641CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
50197106754649CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
10197106780855CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
50197106780853CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
10197106738931CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
50197106738939CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
10197106660010CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106677438CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106660018CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106677436CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106602065CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
50197106602063CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
10197106604434CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
50197106604432CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
50197106583980CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
10197106569122CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106577585CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106569120CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106577583CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106564394CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
50197106564392CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
10197106513279CARDINAL HEALTHCardinal Health 200, LLCLRA2024-01-23
50197106513277CARDINAL HEALTHCardinal Health 200, LLCLRA2024-01-23