FULL-OPTY

Basic Information

• Brand Name: FULL-OPTY
• Primary DI: 08033959221143
• Version / Model: FULL-OPTY
• Catalog Number: FLP1711
• Company Name: STERYLAB SRL
• Labeler DUNS: 439659574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-03
• Public Version: 1
• Public Version Date: 2019-10-11
• Public Version Status: New
• Public Device Record Key: 8ff4917c-696b-47f8-9ada-334adbf971e6

Device Description

Semiautomatic soft tissue biopsy device 17G; 11cm

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: 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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2
FCG	Biopsy Needle	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16835	Soft-tissue biopsy procedure kit, non-medicated	A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18033959221140	GS1		10	In Commercial Distribution
Primary	08033959221143	GS1

Premarket Submissions

Submission Number	Supplement Number
K051506	000