FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594759926
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA18VAAMO
Catalog number
SBA18VAAMO
Device description
25457, CIRCUMCISION PACK
Published
2022-08-12
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
OHGCircumcision tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHGCircumcision TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594759924PackageGS13In Commercial Distribution
10195594759926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559475992450195594759924
1019559475992610195594759926

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. 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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
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
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956487383CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-08
10198956460119CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956460867CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-03
10198956463882CARDINAL HEALTHCardinal Health 200, LLCOHG2026-06-01
10197106867617CARDINAL HEALTHCardinal Health 200, LLCOHG2025-07-28
10197106953488CARDINAL HEALTHCardinal Health 200, LLCOHG2025-06-05
10197106839775CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-27
10197106963036CARDINAL HEALTHCardinal Health 200, LLCOHG2025-05-02
10197106988534CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-11
10197106988848CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990711CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-03
10197106990469CARDINAL HEALTHCardinal Health 200, LLCOHG2025-04-01
10197106983300CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-21
10197106963821CARDINAL HEALTHCardinal Health 200, LLCOHG2025-03-06
10197106920909CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-21
10197106556177CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106919798CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-18
10197106881255CARDINAL HEALTHCardinal Health 200, LLCOHG2025-02-13
10197106824412CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-15
10197106846117CARDINAL HEALTHCardinal Health 200, LLCOHG2025-01-14
10197106864937CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-11
10197106765364CARDINAL HEALTHCardinal Health 200, LLCOHG2024-12-04
10197106829028CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-26
10197106807903CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-25
10197106803172CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106819746CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-13
10197106780510CARDINAL HEALTHCardinal Health 200, LLCOHG2024-11-08
10197106791189CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-31
10197106795729CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-11
10197106739754CARDINAL HEALTHCardinal Health 200, LLCOHG2024-10-01