FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106861271
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
11-6951L
Catalog number
11-6951L
Device description
SHAVE TRAY
Published
2025-02-18
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
OJWShave prep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJWShave Prep KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106861279PackageGS140In Commercial Distribution
10197106861271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710686127950197106861279
1019710686127110197106861271

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956323216CARDINAL HEALTHCardinal Health 200, LLCOJW2026-02-12
10198956251137CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
50198956251135CARDINAL HEALTHCardinal Health 200, LLCOJW2026-01-22
10198956223905CARDINAL HEALTHCardinal Health 200, LLCOJW2025-10-28
50197106861279CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
10197106823378CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
50197106823376CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-13
10197106816233CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
50197106816231CARDINAL HEALTHCardinal Health 200, LLCOJW2024-11-07
10197106731208CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
50197106731206CARDINAL HEALTHCardinal Health 200, LLCOJW2024-08-05
10197106552353CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
50197106552351CARDINAL HEALTHCardinal Health 200, LLCOJW2024-07-12
10197106662984CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
50197106662982CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-25
10197106704004CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
50197106704002CARDINAL HEALTHCardinal Health 200, LLCOJW2024-06-21
10197106441541CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
50197106441549CARDINAL HEALTHCardinal Health 200, LLCOJW2023-11-09
10195594775384CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
50195594775382CARDINAL HEALTHCardinal Health 200, LLCOJW2022-08-10
10195594450755CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
50195594450753CARDINAL HEALTHCardinal Health 200, LLCOJW2021-12-22
10195594432317CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
50195594432315CARDINAL HEALTHCardinal Health 200, LLCOJW2021-11-24
10195594159412CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
50195594159410CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-20
10195594291242CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
50195594291240CARDINAL HEALTHCardinal Health 200, LLCOJW2021-08-19
10195594132217CARDINAL HEALTHCardinal Health 200, LLCOJW2021-07-22