DEVICE: MSI (00810130206209)

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Device Record History
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Device Identifier (DI) Information
MSI
769-01
In Commercial Distribution

Modern Surgical Instruments LLC
00810130206209
GS1

1
118447158 *Terms of Use
BB System Complete Titanium includes: 769-07 BB Retractor Right (1) UDI 00810130200009 769-12 BB Retractor Left (1) UDI 00810130200016 769-17 BB Retractor Offset (1) UDI 00810130200023 769-83 BB Long Rack (1) UDI 00810130200030 769-35 Handle (2) UDI 00810130200047 769-37 Depth Gauge (1) UDI 00810130200054 769-92 Spike Blade (1) UDI 00810130200061 769-95 T-Blade (1) UDI 00810130200078 769-97 Blade (1) UDI 00810130200085 769-91 Instrument Clutch (1) UDI 00810130200092 968-77 Sterilizing Instrument Case with Lid UDI 00810130200108 BB Blades with Teeth 22.5mm x 34mm thru 70mm (2 ea) 769-50 00810130200115 769-51 00810130200122 769-52 00810130200139 769-53 00810130200146 769-54 00810130201372 769-55 00810130200153 769-57 00810130200160 769-59 BB Blade with Teeth 22.5mm x 85mm (1) UDI 00810130200177 769-60 thru 769-67 BB Blades Blunt 22.5mm x 34mm thru 70mm (2 ea) 769-60 00810130200184 769-61 00810130200191 769-62 00810130200207 769-63 00810130200214 769-64 00810130200221 769-65 00810130200238 769-67 00810130200245 769-40 thru 769-42 BB Blades with Teeth 26.5mm x 40mm thru 55mm (4 ea) 769-40 00810130200252 769-41 00810130200269 769-42 00810130200276 769-45 thru 769-47 BB Blades Blunt 26.5mm x 40mm thru 55mm (2 ea) 769-45 00810130200283 769-46 00810130200290 769-47 00810130200306
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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
133ae50c-1121-42fb-ab13-6fafb6772e22
April 30, 2025
1
April 22, 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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