FDA.reportPublic FDA data

Neff

Primary DI
00827002108844
Brand
Neff
Company
COOK INCORPORATED
Model
G10884
Catalog number
NPASW-100-RB
Device description
Neff Percutaneous Access Set
Published
2020-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002108844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002108844008270021088448270021088440827002108844

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08