AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0)

Basic Information

• Brand Name: AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0)
• Primary DI: 07540299000143
• Version / Model: PSZ-400-311
• Company Name: Baylis Medical Technologies Inc
• Labeler DUNS: 240389677
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-16
• Public Version: 1
• Public Version Date: 2022-11-24
• Public Version Status: New
• Public Device Record Key: 23963e7e-627c-43e0-b556-38e77e9ebedb

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: 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
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44093	Arthroscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540299000143	GS1
Previous	00685447001751	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161878	000