DEVICE: MSI (00810130206209)
Device Identifier (DI) Information
MSI
769-01
In Commercial Distribution
Modern Surgical Instruments LLC
769-01
In Commercial Distribution
Modern Surgical Instruments LLC
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
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 |
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
133ae50c-1121-42fb-ab13-6fafb6772e22
April 30, 2025
1
April 22, 2025
April 30, 2025
1
April 22, 2025
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined