FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885425498992
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
16-0006A
Catalog number
16-0006A
Device description
MAYO-HEGAR NEEDLE HOLDER
Published
2016-09-26
Public version status
Update
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
FHQHOLDER, NEEDLE, GASTROENTEROLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425498992PackageGS150In Commercial Distribution
10885425498994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542549899250885425498992
1088542549899410885425498994

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. 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 urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
false
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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621879Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621886Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621893Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621909Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621916Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621923Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621930Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621947Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621954Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621961Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621978Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
G45313110753150PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-05-06
G4254202900My MedicalMy Medical Store LLCFHQ2026-05-04
G4254203160My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209120My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209140My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209170My MedicalMy Medical Store LLCFHQ2026-02-17
G45313110845130PEAK MEDICALPeak Medical Distribution Inc.FHQ2023-07-03
G25004025180Tungsten Carbide Debakey Needle Holder 18cmN S SURGICAL COMPANYFHQ2023-01-27