FDA.reportPublic FDA data

MSI

Primary DI
00810130207206
Brand
MSI
Company
Modern Surgical Instruments LLC
Model
18-5002
Device description
SL Basic Retractor and Distraction System with tray includes18-5012 SL Transverse Retractor Lateral Feed Opening Width 150mm (1), 0081013020060318-5005 SL Longitudinal Retractor Frame lateral feed (1), UDI 0081013020112918-6060 SL Color Coded Depth Gauge (1), UDI 0081013020075717-4120 Caspar Spinal Spreader, Right, Rack 130mm (1), UDI 0081013020065817-4105 Caspar Spinal Spreader, Left, Rack 130mm (1), UDI 0081013020067217-4623 Caspar Screwdriver with black Radel handle (PPSU) (2), UDI 0081013020073317-4422 Drill Guide for Caspar Spinal Spreader Left with Black Radel Handle 16 x 20mm (1), UDI 0081013020071917-4424 Drill Guide for Caspar Spinal Spreader Right with Black Radel Handle 16 x 20mm (1), UDI 0081013020072617-4802 Caspar spinal spreader Twist Drill long drill length 14 mm, shaft Ø 8 mm total length 148 mm (1), UDI 0081013020418218-5020 SL Locking Retractor Handle, lateral feed (1), UDI 0081013020070229-6894 Tray with inlays SL ACF, 540 X 253 X 170mm (1), UDI 0081013020074018-5130 SL Tissue Blade 30mm Blunt, Silver, anodized Natural (2), UDI 0081013020076418-5135 SL Tissue Blade 35mm Blunt Anodized Dark Blue (2), UDI 0081013020077118-5140 SL Tissue Blade 40mm Blunt Anodized Dark Red (2), UDI 0081013020078818-5145 SL Tissue Blade 45mm Blunt Anodized Olive Green (2), UDI 0081013020079518-5150 SL Tissue Blade 50mm Anodized Dark Violet (2), UDI 0085001762611918-5155 SL Tissue Blade 55mm Blunt Anodized Black (2), UDI 0081013020080118-5160 SL Tissue Blade 60mm Blunt Anodized Dark Gold (2), UDI 0081013020081818-5165 SL Tissue Blade 65mm Blunt Anodized Titanium (2), UDI 0081013020082518-5170 SL Tissue Blade 70mm Blunt Anodized Yellow (2), UDI 0081013020083218-5175 SL Tissue Blade 75mm Blunt Anodized Dark Orange (2), UDI 0081013020084918-5330 SL Medial Muscle Blade 30mm Long Teeth Anodized Natural (1), UDI 0081013020093118-5335 SL Medial Muscle Blade 35mm Long Teeth Anodized Dark Blue (1), UDI 0081013020094818-5340 SL Med
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810130207206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810130207206008101302072068101302072060810130207206

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118447158
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810130207435MSI100012026-07-14
00810130207411MSI769-022026-05-12
00810130207404MSI83.72902026-04-01
00810130207367MSI99-00462026-03-12
00810130207374MSI99-00362026-03-12
00810130207381MSI99-00472026-03-12
00810130207398MSI99-00372026-03-12
00810130207350MSI47-03702026-02-20
00810130207343MSI71102026-02-16
B4194907540MSI49-07542022-08-03
B4197129690MSI71-29692022-08-02
00810130207336MSI42-08242026-01-23
00810130207329MSIFSP10012025-12-23
00810130207312MSIFSP31132025-12-19
00810130207213MSIFSP1856-12025-12-02
00810130207220MSIFSP1856-22025-12-02
00810130207237MSIFSP1856-32025-12-02
00810130207244MSIFSP1856-42025-12-02
00810130207251MSIFSP1856-52025-12-02
00810130207268MSIFSP1856-72025-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD77550140Surgical DirectSurgical Direct, Inc.FFO2026-07-14
B382SD918174150Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD9183701030Surgical DirectSurgical Direct, Inc.FFO2026-07-13
B382SD484610Surgical DirectSurgical Direct, Inc.FFO2026-07-09
B382SD484630Surgical DirectSurgical Direct, Inc.FFO2026-07-09