SonoTip II EBUS

Basic Information

• Brand Name: SonoTip II EBUS
• Primary DI: 04052838011099
• Version / Model: GUS-21-18-022
• Catalog Number: GUS-21-18-022
• Company Name: Medi-Globe GmbH
• Labeler DUNS: 318130267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 475ed67e-c578-4ce3-815c-50758a26224f

Device Description

SonoTip II EBUS-TBNA Neelde-System for Pentax Endoscope, 22 Gauge needle, round Nitinol stylet, needle ø 0.7 mm, outer ø 1.8 mm

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10403	Ultrasound aspiration biopsy procedure kit	A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04052838011082	GS1	Box	5	In Commercial Distribution
Primary	04052838011099	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	22	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight.