Surge Cardiovascular

Basic Information

• Brand Name: Surge Cardiovascular
• Primary DI: 00817278010033
• Version / Model: 213-010
• Catalog Number: 213-010
• Company Name: Med Michigan Holdings, LLC
• Labeler DUNS: 097462979
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2022-09-21
• Public Version Status: Update
• Public Device Record Key: d1cb743e-f51c-498f-8aa1-befe39b758cf

Device Description

Suture Guide, Single Pack

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEJ	Carrier, Ligature	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13895	Operative-site suture holder	A device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817278010033	GS1