Robotic Suture Hook Left

Basic Information

• Brand Name: Robotic Suture Hook Left
• Primary DI: B040RSHL0
• Version / Model: RSH-L
• Company Name: GENESEE BIOMEDICAL, INC.
• Labeler DUNS: 939872651
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-05
• Public Version: 1
• Public Version Date: 2024-12-13
• Public Version Status: New
• Public Device Record Key: 99ded987-f67d-42e3-94fe-7bf85b0b7185

Device Description

Suture Hook with Left curl

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63597	Ligature loop applier	A hand-held manual surgical instrument designed for the application of a ligature loop (e.g., wire, suture, tubing) around a blood vessel, or other tissue, for occlusion during open surgery. It is typically a slender rod with a hook at the distal end; it does not include a ligature passing mechanism (i.e., not a passer). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B040RSHL1	HIBCC		1	In Commercial Distribution
Primary	B040RSHL0	HIBCC