TSI
Insulated Dilator, Grooved, 8, 13 & 18 MM, Sterile
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Tedan Surgical Innovations, L.L.C. |
|---|---|
| FDA product code | PDQ |
| Device type | Neurosurgical Nerve Locator |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| 510(k) | K140088 |
| Record published | 2016-05-05 |
| Record revised | 2023-06-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 7 to 22 mm |
| Distribution end date | 2023-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ML-0441S | Width 18 mm | In distribution |
| ML-0449S | Width 22 mm | In distribution |
| ML-0444S | Width 14.9 mm | In distribution |
| ML-0443S | Width 22 mm | Withdrawn |
| ML-0342 | Withdrawn | |
| ML-0440S | Withdrawn | |
| ML-0342-100 | Withdrawn | |
| ML-0440S | Width 8 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulse | Nuvasive, Inc. | 21 |
| Pediguard Threaded | Spineguard, SA | 19 |
| NVM5 | Nuvasive, Inc. | 15 |
| Alara Neuro Access Needle Kit | Surgentec LLC | 12 |
| SafeOp | Alphatec Spine, Inc. | 9 |
| Sentio | Medos International Sàrl | 8 |
| SentioMMG | Innovative Surgical Solutions LLC | 7 |
| PediGuard DSG Connect | Spineguard, SA | 6 |
| Fresh Whole Blood Donor Transfusion Set | Safeguard US Operating, LLC | 5 |
| Arcus | Alphatec Spine, Inc. | 4 |
| Bendini | Nuvasive, Inc. | 4 |
| Boston Endo Surgical Technologies LLC | Lacey Manufacturing Company LLC | 4 |
Showing 12 of 63. All products under Neurosurgical Nerve Locator
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.