MSI
Basic Information
- Brand Name
- MSI
- Primary DI
- 00810130206209
- Version / Model
- 769-01
- Company Name
- Modern Surgical Instruments LLC
- Labeler DUNS
- 118447158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-22
- Public Version
- 1
- Public Version Date
- 2025-04-30
- Public Version Status
- New
- Public Device Record Key
- 133ae50c-1121-42fb-ab13-6fafb6772e22
Device Description
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810130206209 | GS1 |