SI-RESTORE
GUDID 00850073363416
DRILL, 11.0MM
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
Cannulated surgical drill bit, reusable| Primary Device ID | 00850073363416 |
| NIH Device Record Key | 38f71e01-a517-4282-947c-f40fd675416f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SI-RESTORE |
| Version Model Number | 1701-300110 |
| Company DUNS | 125905168 |
| Company Name | BIOFUSION MANAGEMENT AND MANUFACTURING, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
| Outer Diameter | 11 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850073363416 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182919
FDA Product Code
| HTW | Bit, Drill |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
[00850073363416]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-25 |
| Device Publish Date | 2025-03-17 |
On-Brand Devices [SI-RESTORE]
| 00850073363614 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 65MM |
| 00850073363607 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 60MM |
| 00850073363591 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 55MM |
| 00850073363584 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 50MM |
| 00850073363577 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 45MM |
| 00850073363560 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 40MM |
| 00850073363553 | SI-RESTORE SCREW, HA BLASTED, 11.0MM x 35MM |
| 00850073363546 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 65MM |
| 00850073363539 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 60MM |
| 00850073363522 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 55MM |
| 00850073363515 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 50MM |
| 00850073363508 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 45MM |
| 00850073363492 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 40MM |
| 00850073363485 | SI-RESTORE SCREW, HA BLASTED, 9.5MM x 35MM |
| 00850073363133 | SI-RESTORE SCREW, 11.0MM x 65MM |
| 00850073363126 | SI-RESTORE SCREW, 11.0MM x 60MM |
| 00850073363119 | SI-RESTORE SCREW, 11.0MM x 55MM |
| 00850073363102 | SI-RESTORE SCREW, 11.0MM x 50MM |
| 00850073363096 | SI-RESTORE SCREW, 11.0MM x 45MM |
| 00850073363089 | SI-RESTORE SCREW, 11.0MM x 40MM |
| 00850073363072 | SI-RESTORE SCREW, 11.0MM x 35MM |
| 00850073363065 | SI-RESTORE SCREW, 9.5MM x 50MM |
| 00850073363058 | SI-RESTORE SCREW, 9.5MM x 50MM |
| 00850073363041 | SI-RESTORE SCREW, 9.5MM x 50MM |
| 00850073363034 | SI-RESTORE SCREW, 9.5MM x 50MM |
| 00850073363027 | SI-RESTORE SCREW, 9.5MM x 45MM |
| 00850073363010 | SI-RESTORE SCREW, 9.5MM x 40MM |
| 00850073363003 | SI-RESTORE SCREW, 9.5MM x 35MM |
| 00850073363638 | DOUBLE BARREL PIN GUIDE |
| 00850073363621 | T-HANDLE, 1/4" SQUARE, RATCHETING |
| 00850073363430 | TAP, 11.0MM |
| 00850073363423 | TAP, 9.5MM |
| 00850073363416 | DRILL, 11.0MM |
| 00850073363409 | DRILL, 9.5MM |
| 00850073363393 | SMOOTH DILATOR 3 |
| 00850073363386 | STEINMANN PIN EXTENDER |
| 00850073363379 | STEINMANN PIN, 3.2MM, SHARP, EXTENDABLE |
| 00850073363362 | TRI-GUIDE |
| 00850073363355 | DILATOR HANDLE |
| 00850073363348 | STEINMANN PIN HOLDER |
| 00850073363331 | 16MM FIXED GUIDE BUMPER |
| 00850073363324 | 14MM FIXED GUIDE BUMPER |
| 00850073363317 | DILATOR 1 GAUGE |
| 00850073363300 | IMPLANT GRAFT FILLER POST |
| 00850073363294 | SCREWDRIVER |
| 00850073363287 | 16MM GUIDE |
| 00850073363270 | MALLET |
| 00850073363263 | SLAP HAMMER |
| 00850073363256 | BONE GRAFT PLUNGER |
| 00850073363249 | BONE GRAFT FUNNEL |
Trademark Results [SI-RESTORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SI-RESTORE 87849969 5747103 Live/Registered |
Bio Fusion Medical 2018-03-26 |
 SI-RESTORE 87849933 5747100 Live/Registered |
Bio Fusion Medical 2018-03-26 |
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