Aesclepius Suture Cinch, Case of 5 Suture Cinch Packs

Basic Information

• Brand Name: Aesclepius Suture Cinch, Case of 5 Suture Cinch Packs
• Primary DI: G485AESC2001CS2
• Version / Model: AESC-2001-CS
• Company Name: Aesclepius Corporation
• Labeler DUNS: 080782056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-01-13
• Public Version: 1
• Public Version Date: 2025-01-21
• Public Version Status: New
• Public Device Record Key: e528c9eb-d5a3-401c-a451-fed98671ea90

Device Description

Case of 5 Suture Cinch Packs, each with two Suture Cinches with curled nitinol snare

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: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63560	Wire/ligature passer, single-use	A sterile, hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G485AESC2001CS2	HIBCC
Unit of Use	G485AESC20010	HIBCC

Customer Contacts

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