0.016" Stylet, 1235mm L

Basic Information

• Brand Name: 0.016" Stylet, 1235mm L
• Primary DI: 00815686021191
• Version / Model: INS-5411
• Catalog Number: INS-5411
• Company Name: VERAN MEDICAL TECHNOLOGIES INC.
• Labeler DUNS: 181714804
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-30
• Public Version: 4
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 25f2e7c3-df8c-4722-a5c0-a25a5c5b7369
• Distribution End Date: 2023-08-10

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: Yes
• 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
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38562	Lung biopsy procedure kit	A collection of sterile devices designed to perform a histologic specimen aspiration during a percutaneous lung biopsy. It typically includes a biopsy needle and other supplies to perform this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10815686021198	GS1		5	Not in Commercial Distribution	2023-08-10
Primary	00815686021191	GS1

Premarket Submissions

Submission Number	Supplement Number
K170023	000