SPiN Perc Biopsy Needle Guide Kit - 20cm

Basic Information

• Brand Name: SPiN Perc Biopsy Needle Guide Kit - 20cm
• Primary DI: 00815686021122
• Version / Model: INS-5620
• Catalog Number: INS-5620
• 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: 2018-01-25
• Public Version: 7
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 2810f20b-568e-462d-a9ce-2f59a6cec990
• Distribution End Date: 2023-08-10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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
Primary	00815686021122	GS1
Package	10815686021129	GS1		5	Not in Commercial Distribution	2023-08-10

Premarket Submissions

Submission Number	Supplement Number
K170023	000