Total Abscession

Basic Information

• Brand Name: Total Abscession
• Primary DI: H787140010080
• Version / Model: 14001008
• Company Name: ANGIODYNAMICS, INC.
• Labeler DUNS: 079105071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-16
• Public Version: 3
• Public Version Date: 2019-02-12
• Public Version Status: Update
• Public Device Record Key: ca133d8e-cff2-44fa-bf7e-7f3e29fd279f

Device Description

12F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBO	CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10735	Nephrostomy catheter	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H787140010085	HIBCC	BOX	5	In Commercial Distribution
Primary	H787140010080	HIBCC
Secondary	15051684011655	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	45	Centimeter
Catheter Gauge	12	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 27 Degrees Celsius