MSI

Basic Information

• Brand Name: MSI
• Primary DI: 00810130206223
• Version / Model: 18-5000
• Company Name: Modern Surgical Instruments LLC
• Labeler DUNS: 118447158
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-25
• Public Version: 1
• Public Version Date: 2025-05-05
• Public Version Status: New
• Public Device Record Key: 00a63348-706a-4b04-a60c-3cc59c656a56

Device Description

SL Retractor and Distraction System with tray includes 18-5010 SL Transverse retractor, lateral feed, opening width 120mm (1), UDI 00810130200689 18-5005 SL Longitudinal Retractor Frame lateral feed (1), UDI 00810130201129 17-4120 Caspar Spinal Spreader, Right, Rack 130mm (1), UDI 00810130200658 17-4105 Caspar Spinal Spreader, Left, Rack 130mm (1), UDI 00810130200672 17-4115 Caspar Spinal Spreader, Right Short, Rack 110mm (1), UDI 00810130200641 17-4100 Caspar Spinal Spreader Left Short, Rack 110mm (1), UDI 00810130200665 17-4623 Caspar Screwdriver with black Radel handle (PPSU) (2), UDI 00810130200733 18-6060 SL Color Coded Depth Gauge (1), UDI 00810130200757 18-5020 SL Locking Retractor Handle, lateral feed (1), UDI 00810130200702 29-6894 Tray with inlays SL ACF, 540 X 253 X 170mm (1), UDI 00810130200740 18-5130 SL Tissue Blade 30mm Blunt, Silver, anodized Natural (2), UDI 00810130200764 18-5135 SL Tissue Blade 35mm Blunt Anodized Dark Blue (2), UDI 00810130200771 18-5140 SL Tissue Blade 40mm Blunt Anodized Dark Red (2), UDI 00810130200788 18-5145 SL Tissue Blade 45mm Blunt Anodized Olive Green (2), UDI 00810130200795 18-5150 SL Tissue Blade 50mm Anodized Dark Violet (2), UDI 00850017626119 18-5155 SL Tissue Blade 55mm Blunt Anodized Black (2), UDI 00810130200801 18-5160 SL Tissue Blade 60mm Blunt Anodized Dark Gold (2), UDI 00810130200818 18-5165 SL Tissue Blade 65mm Blunt Anodized Titanium (2), UDI 00810130200825 18-5170 SL Tissue Blade 70mm Blunt Anodized Yellow (2), UDI 00810130200832 18-5175 SL Tissue Blade 75mm Blunt Anodized Dark Orange (2), UDI 00810130200849 18-5330 SL Medial Muscle Blade 30mm Long Teeth Anodized Natural (1), UDI 00810130200931 18-5335 SL Medial Muscle Blade 35mm Long Teeth Anodized Dark Blue (1), UDI 00810130200948 18-5340 SL Medial Muscle Blade 40mm Long Teeth Anodized Dark Red (1), UDI 00810130200955 18-5345 SL Medial Muscle Blade 45mm Long Teeth Anodized Olive Green (1), UDI 00810130200962 18-5350 SL Medial Mu

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: 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: No
• 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
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810130206223	GS1