DEVICE: MSI (00810130206018)

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Device Record History
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Device Identifier (DI) Information
MSI
769-03
In Commercial Distribution

Modern Surgical Instruments LLC
00810130206018
GS1

1
118447158 *Terms of Use
769-07 BB Retractor Right (Titanium) UDI 00810130200009 769-12 BB Retractor Left (Titanium) UDI 00810130200016 769-17 BB Retractor Offset (Titanium ) UDI 00810130200023 769-35 Blade Inserting Handle UDI 00810130200047 769-50 BB Blade with Teeth (Titanium) 22.5mm x 34mm UDI 00810130200115 769-51 BB Blade with Teeth (Titanium) 22.5mm x 40mm UDI 00810130200122 769-52 BB Blade with Teeth (Titanium) 22.5mm x 45mm UDI 00810130200139 769-53 BB Blade with Teeth (Titanium) 22.5mm x 50mm UDI 00810130200146 769-54 BB Blade with Teeth (Titanium ) 22.5mm x 55mm UDI 00810130201372 769-55 BB Blade with Teeth (Titanium) 22.5mm x 60mm UDI 00810130200153 769-57 BB Blade with Teeth (Titanium) 22.5mm x 70mm UDI 00810130200160 769-60 BB Blunt Blade (Titanium) 22.5mm x 34mm UDI 00810130200184 769-61 BB Blunt Blade (Titanium) 22.5mm x 40mm UDI 00810130200191 769-62 BB Blunt Blade (Titanium) 22.5mm x 45mm UDI 00810130200207 769-63 BB Blunt Blade (Titanium) 22.5mm x 50mm UDI 00810130200214 769-64 BB Blunt Blade (Titanium) 22.5mm x 55mm UDI 00810130200221 769-65 BB Blunt Blade (Titanium) 22.5mm x 60mm UDI 00810130200238 769-67 BB Blunt Blade (Titanium) 22.5mm x 70mm UDI 00810130200245 769-40 BB Blade with Teeth (Titanium) 26.5mm x 40mm UDI 00810130200252 769-41 BB Blade with Teeth (Titanium) 26.5mm x 47mm UDI 00810130200269 769-42 BB Blade with Teeth (Titanium) 26.5mm x 55mm UDI 00810130200276 769-45 BB Blunt Blade (Titanium) 26.5mm x 40mm UDI 00810130200283 769-46 BB Blunt Blade (Titanium) 26.5mm x 47mm UDI 00810130200290 769-47 BB Blunt Blade (Titanium) 26.5mm x 55mm UDI 00810130200306 968-77 Sterilizing Instrument Case with Lid UDI 00810130200108
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
FFO Retractor, Self-Retaining
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7ecef3c7-ba63-4bdd-8e07-a2463038a67f
April 18, 2025
1
April 10, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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