FDA.reportPublic FDA data

Amplatz

Primary DI
00827002312555
Brand
Amplatz
Company
COOK INCORPORATED
Model
G31255
Catalog number
ULT14.0-38-50-P-6S-AUDC-PIG-WF
Device description
Amplatz Universal Drainage Catheter Ultrathane
Published
2020-10-02
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002312555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002312555008270023125558270023125550827002312555

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
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
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15051684011600Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011617Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011624Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011631Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011648Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011655Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011662Total AbscessionAngiodynamics, Inc.GBO2024-10-30
00812261011806allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012308allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012315allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261019222allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-09
00812261012292allDrainALLWIN MEDICAL DEVICES, INC.GBO2024-01-08
00812261012285allDrainALLWIN MEDICAL DEVICES, INC.GBO2023-07-28
00817640020103Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020110Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020202Aspiration and Flush AssemblyURESIL, LLCGBO2022-05-19
00817640020097GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020219GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-29
00817640020035GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020042GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020066GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020073GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020080GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-28
00817640020059GP General Purpose Drainage CatheterURESIL, LLCGBO2022-04-26
H862MPL2T1230H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862MPLT21430H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-10
H862GPJT0620H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09
H862GPJT0825H0GP General Purpose Drainage CatheterURESIL, LLCGBO2021-06-09