FDA.reportPublic FDA data

Total Abscession

Primary DI
15051684011600
Brand
Total Abscession
Company
Angiodynamics, Inc.
Model
H787140010030
Catalog number
14001003
Device description
10F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
Published
2024-10-30
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
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
25051684011607PackageGS15In Commercial Distribution
H787140010030PreviousHIBCC0
15051684011600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505168401160725051684011607
1505168401160015051684011600

GMDN Terms#

Term, Definition table
TermDefinition
Nephrostomy catheterA sterile, flexible tube intended to be inserted percutaneously into the renal pelvis to gain access to the upper urinary tract. This device consists of a large-bore (sizes from 14 to 24 Fr are typical), thin-walled tube usually with a self-retained tip; it sometimes has expanding wings on its tip. It is used to perform drainage for relief of supravesicular obstructions and may also be intended for a variety of procedures of the upper urinary tract including dilation of strictures, removal of calculi, perfusion with chemolytic agents for dissolution of renal stones, or ureteral stenting. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)772-6446customerservice@angiodynamics.com

Regulatory Flags#

DUNS number
079252781
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23
05051684018503LifeportH787LPS30070LPS30072026-06-23
05051684018510LifeportH787LPS30080LPS30082026-06-23
05051684018527LifeportH787LPS30090LPS30092026-06-23
05051684018534LifeportH787LPS30170LPS30172026-06-23
05051684018541LifeportH787LPS30230LPS30232026-06-23
05051684018558LifeportH787LPS30250LPS30252026-06-23
05051684018565LifeguardH787LG191000LG-19-1002026-06-23
05051684018572LifeguardH787LG19750LG-19-752026-06-23
05051684018589LifeguardH787LG201000LG-20-1002026-06-23
05051684018596LifeguardH787LG201500LG-20-1502026-06-23
05051684018602LifeguardH787LG20500LG-20-502026-06-23
05051684018619LifeguardH787LG20750LG-20-752026-06-23
05051684018626LifeguardH787LG221000LG-22-1002026-06-23
05051684018633LifeguardH787LG22500LG-22-502026-06-23
05051684018640LifeguardH787LG22750LG-22-752026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15051684011587Total AbscessionAngiodynamics, Inc.GBO2024-10-30
15051684011594Total 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
00817640020226GP 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