AccessGUDID - DEVICE: MSI (00810130206223)

GUDID

Device Identifier (DI) Information

Brand Name: MSI
Version or Model: 18-5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Modern Surgical Instruments LLC

Primary DI Number: 00810130206223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118447158 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFO	Retractor, Self-Retaining

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00a63348-706a-4b04-a60c-3cc59c656a56
Public Version Date: May 05, 2025
Public Version Number: 1
DI Record Publish Date: April 25, 2025