FDA.reportPublic FDA data

Cook

Primary DI
00827002102613
Brand
Cook
Company
COOK INCORPORATED
Model
G10261
Catalog number
CLM-12.0-RH-NPAS-NT
Device description
Multipurpose Drainage Catheter Set Neff Access Set with Nitinol Wire Guide Ultrathane
Published
2020-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBOCATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
LJECATHETER, NEPHROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBOCatheter, Nephrostomy, General & Plastic SurgeryGeneral, Plastic Surgery1
LJECatheter, NephrostomyUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002102613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002102613008270021026138270021026130827002102613

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose percutaneous abdominothoracic drainage catheterA flexible tube intended for percutaneous introduction into two or more abdominothoracic anatomies (nephrostomy, biliary, abscess, pleural, peritoneal, mediastinal) [i.e., multi-purpose] for intermittent or long-term drainage. It is available in various designs, shapes, and sizes, and is often designed to be connected to a pleural/peritoneal cavity suction (drainage) system. Disposable devices dedicated to catheter introduction may be included with the device. 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
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

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Primary DI, Brand, Company table
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25051684011591Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011607Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011614Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011621Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011638Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011645Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011652Total AbscessionAngiodynamics, Inc.GBO2024-10-30
25051684011669Total AbscessionAngiodynamics, Inc.GBO2024-10-30
04046955638406ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638581ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638604ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638741ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638789ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638840ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638888ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955638963ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
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04046955639120ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639144ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639182ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
04046955639205ACCEL®B BRAUN INTERVENTIONAL SYSTEMS, INCGBO2024-05-12
10812261012282allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
05701780270878KolibriColoplast A/SLJE2023-01-20