BEST-LISAS

Basic Information

• Brand Name: BEST-LISAS
• Primary DI: 08033959222577
• Version / Model: BEST-LISAS
• Catalog Number: BSL1309
• Company Name: STERYLAB SRL
• Labeler DUNS: 439659574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-02
• Public Version: 1
• Public Version Date: 2019-10-10
• Public Version Status: New
• Public Device Record Key: 670c9455-466e-482e-b404-49a32513e3bc

Device Description

Bone marrow biopsy needle 13G x 9cm

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

GMDN Terms

Code	Name	Definition	Implantable	Status
16833	Bone marrow biopsy procedure kit	A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18033959222574	GS1		20	In Commercial Distribution
Primary	08033959222577	GS1

Premarket Submissions

Submission Number	Supplement Number
K051506	000