FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594724993
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA4FDCCFA
Catalog number
SMA4FDCCFA
Device description
D C PACK
Published
2022-10-04
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
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594724991PackageGS19In Commercial Distribution
10195594724993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559472499150195594724991
1019559472499310195594724993

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.

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
08809260472037TRAUSSaeshin Precision Co., Ltd.HAB2026-05-07
08809260471924TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471931TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471948TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471955TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471962TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471979TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471986TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471993TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472006TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472013TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472020TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473041TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473058TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473065TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473072TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473089TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473096TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473102TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
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30653405990745Hall® Titan™Conmed CorporationHAB2025-12-29
10653405005513HALLConmed CorporationHAB2023-12-04
10653405005711HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005728HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005735HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005742HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005759HALL MICROFREEConmed CorporationHAB2023-10-12
00885556826676First Choice DRUJ SystemSmith & Nephew, Inc.HAB2023-08-02
00885556856840Ascension MCP Joint ReplacementSmith & Nephew, Inc.HAB2023-08-02
00885556857663NuGrip CMCSmith & Nephew, Inc.HAB2023-08-02