FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488809241
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
12-0940B
Catalog number
12-0940B
Device description
STERILE NEEDLE HOLDER KIT
Published
2017-10-02
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
50887488809241PackageGS120In Commercial Distribution
10887488809243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748880924150887488809241
1088748880924310887488809243

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
G453230117BCL0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
G453230117BCR0PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-03-23
04059453049339Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFHQ2026-03-10
B382SD9056641000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
B382SD9056791000Surgical DirectSurgical Direct, Inc.FHQ2026-03-09
00192896106833Matthieu Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-02-26
B382SD905662170Surgical DirectSurgical Direct, Inc.FHQ2026-02-20
G4254202130My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202200My MedicalMy Medical Store LLCFHQ2026-02-17
G4254202240My MedicalMy Medical Store LLCFHQ2026-02-17
B382SD905434160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD90548817LH0Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9055891110Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9056791160Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
B382SD9084551100Surgical DirectSurgical Direct, Inc.FHQ2026-02-05
00192896122628Glasser Micro Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00192896122673Derf Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-01-22
00848657076012AED 6250 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Left JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
00848657076029AED 6252 Mathieu Handle Laparoscopic Needle Holder, 33cm, Curved Right JawNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FHQ2026-01-15
D928301140LH0NEEDLE HOLDER MAYO-HEGAR 7" LEFT HAND TCW.H. Holden, Inc.FHQ2026-01-05
D9283011450NEEDLE HOLDER MAYO-HEGAR 8" / 20CM TCW.H. Holden, Inc.FHQ2026-01-05
D9283011510NEEDLE HOLDER OLSEN-HEGAR 4 1/2" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011570NEEDLE HOLDER OLSEN-HEGAR 7 1/4" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011600NEEDLE HOLDER RYDER 5 1/8" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011640NEEDLE HOLDER FRENCH RYDER 9" TCW.H. Holden, Inc.FHQ2026-01-05
D9283011650NEEDLE HOLDER HEANEY 8 1/4" - 20CMW.H. Holden, Inc.FHQ2026-01-05
D928301173OS0NEEDLE HOLDER MINI-RYDER 6" SM OFF SET HANDLEW.H. Holden, Inc.FHQ2026-01-05
D92830117470NEEDLE HOLDER MINI-RYDER 7" TC NEW PATTERNW.H. Holden, Inc.FHQ2026-01-05
D928301174D0NEEDLE HOLDER MINI-RYDER 7" DELICATE, TC SERRATEDW.H. Holden, Inc.FHQ2026-01-05