FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106552351
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
11-6951J
Catalog number
11-6951J
Device description
SHAVE TRAY
Published
2024-07-12
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
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
50197106552351PackageGS140In Commercial Distribution
10197106552353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710655235150197106552351
1019710655235310197106552353

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

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

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
10197106861271CARDINAL HEALTHCardinal Health 200, LLCOJW2025-02-18
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
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