MSI
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Basic Information
- Brand Name
- MSI
- Primary DI
- 00810130207206
- Version / Model
- 18-5002
- Company Name
- Modern Surgical Instruments LLC
- Labeler DUNS
- 118447158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-18
- Public Version
- 1
- Public Version Date
- 2025-11-26
- Public Version Status
- New
- Public Device Record Key
- 443ff49c-8bd5-416d-a19e-df6f5455f2f1
Device Description
SL Basic Retractor and Distraction System with tray includes 18-5012 SL Transverse Retractor Lateral Feed Opening Width 150mm (1), 00810130200603 18-5005 SL Longitudinal Retractor Frame lateral feed (1), UDI 00810130201129 18-6060 SL Color Coded Depth Gauge (1), UDI 00810130200757 17-4120 Caspar Spinal Spreader, Right, Rack 130mm (1), UDI 00810130200658 17-4105 Caspar Spinal Spreader, Left, Rack 130mm (1), UDI 00810130200672 17-4623 Caspar Screwdriver with black Radel handle (PPSU) (2), UDI 00810130200733 17-4422 Drill Guide for Caspar Spinal Spreader Left with Black Radel Handle 16 x 20mm (1), UDI 00810130200719 17-4424 Drill Guide for Caspar Spinal Spreader Right with Black Radel Handle 16 x 20mm (1), UDI 00810130200726 17-4802 Caspar spinal spreader Twist Drill long drill length 14 mm, shaft Ø 8 mm total length 148 mm (1), UDI 00810130204182 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 Med
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 | 00810130207206 | GS1 |