NA

Basic Information

• Brand Name: NA
• Primary DI: 08714729077756
• Version / Model: M0067001220
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 781cb13c-24e2-48d9-8c51-1c382b2738e0

Device Description

Percutaneous Access Needle

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
61503	Nephrostomy catheter introduction needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729077756	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 cm Effective Length
Device Size Text, specify			18 ga Diameter
Device Size Text, specify			1.3 mm Diameter