| Primary Device ID | 00843059126976 |
| NIH Device Record Key | 5d297c10-6306-4564-8663-8cf73b753335 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSI |
| Version Model Number | ML-0715 |
| Company DUNS | 791619393 |
| Company Name | TEDAN SURGICAL INNOVATIONS, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00843059126976 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
[00843059126976]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-19 |
| Device Publish Date | 2024-11-11 |
| 00851797006993 | U-BAR, FRONT |
| 00851797006986 | U-BAR, SIDE |
| 00851797006979 | VERTICAL POST, FRONT |
| 00851797006962 | VERTICAL POST, REAR |
| 00851797006955 | DUAL STARBURST TABLE CLAMP |
| 00851797006948 | SKULL CLAMP DUAL FLEX ARM HOLDER |
| 00851797006931 | SINGLE FLEX ARM HOLDER |
| 00851797006924 | UNIVERSAL SPATULA HOLDER |
| 00851797006917 | SPATULA HOLDER |
| 00851797006900 | PATTIE TRAY |
| 00851797006894 | NEURO FLEX ARM, 16.5CM (6.5") |
| 00851797006887 | NEURO FLEX ARM, 42CM (16.5") |
| 00851797006870 | NEURO FLEX ARM, 38CM (14.5") |
| 00851797006863 | LIGHT CABLE, STANDARD CURVE, 10' |
| 00851797006856 | FLEX ARM LIGHT CABLE HOLDER, LARGE |
| 00851797006849 | STERILIZATION TRAY, ML-2009 |
| 00851797006832 | ANGLED ARTICULATING ARM, RACK CLAMP |
| 00851797006825 | ROTATABLE TABLE CLAMP |
| 00851797006818 | CONCAVE SPATULA, 75 MM, 20 MM, SST |
| 00851797006801 | CONCAVE SPATULA, 75 MM, 16 MM, SST |
| 00851797006795 | CONCAVE SPATULA, 75 MM, 13 MM, SST |
| 00851797006788 | CONCAVE SPATULA, 75 MM, 10 MM, SST |
| 00851797006771 | CONCAVE SPATULA, 75 MM, 8 MM, SST |
| 00851797006764 | CONCAVE SPATULA, 75 MM, 5 MM, SST |
| 00851797006757 | CONCAVE SPATULA, 65 MM, 20 MM, SST |
| 00851797006740 | CONCAVE SPATULA, 65 MM, 16 MM, SST |
| 00851797006733 | CONCAVE SPATULA, 65 MM, 13 MM, SST |
| 00851797006726 | CONCAVE SPATULA, 65 MM, 10 MM, SST |
| 00851797006719 | CONCAVE SPATULA, 65 MM, 8 MM, SST |
| 00851797006702 | CONCAVE SPATULA, 65 MM, 5 MM, SST |
| 00851797006696 | CONCAVE SPATULA, 45 MM, 20 MM, SST |
| 00851797006689 | CONCAVE SPATULA, 45 MM, 16 MM, SST |
| 00851797006672 | CONCAVE SPATULA, 45 MM, 13 MM, SST |
| 00851797006665 | CONCAVE SPATULA, 45 MM, 10 MM, SST |
| 00851797006658 | CONCAVE SPATULA, 45 MM, 8 MM, SST |
| 00851797006641 | CONCAVE SPATULA, 45 MM, 5 MM, SST |
| 00851797006634 | DAVIS STYLE SPATULA, 38 MM, SST |
| 00851797006627 | DAVIS STYLE SPATULA, 38 MM, SST |
| 00851797006610 | DAVIS STYLE SPATULA, 32 MM, SST |
| 00851797006603 | DAVIS STYLE SPATULA, 25 MM, SST |
| 00851797006597 | DAVIS STYLE SPATULA, 19 MM, SST |
| 00851797006580 | DAVIS STYLE SPATULA, 16 MM, SST |
| 00851797006573 | DAVIS STYLE SPATULA, 13 MM, SST |
| 00851797006566 | DAVIS STYLE SPATULA, 10 MM, SST |
| 00851797006559 | DAVIS STYLE SPATULA, 6 MM, SST |
| 00851797006542 | MALLEABLE TAPERED SPATULA, 200 MM, 7.0 MM, SST |
| 00851797006535 | MALLEABLE TAPERED SPATULA, 200 MM, 5.8 MM, SST |
| 00851797006528 | MALLEABLE TAPERED SPATULA, 200 MM, 3.8 MM, SST |
| 00851797006511 | MALLEABLE TAPERED BRAIN SPATULA 200 MM, 2.2 MM, SST |
| 10851797006501 | LIGHT CABLE, 10', STERILE, 5/BOX |