NA

Basic Information

• Brand Name: NA
• Primary DI: 08714729005469
• Version / Model: M0062601040
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: c425b6b4-b965-46ad-8675-39636ae8942b

Device Description

Amplatz Type Renal Dilator

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
GCC	Dilator, catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47796	Multi-purpose percutaneous abdominothoracic drainage catheter	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729005469	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.7 mm Diameter
Device Size Text, specify			14 F Diameter
Device Size Text, specify			35 cm Length