| Primary Device ID | 00843059124569 |
| NIH Device Record Key | 9a8f1b2f-aa11-45cc-9c3b-2cbf880c2263 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RTI |
| Version Model Number | 19-DILATOR-18 |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00843059124569 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
[00843059124569]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-23 |
| Device Publish Date | 2020-06-15 |
| 00843059119565 | CLARITY PORT SYSTEM STERILIZATION TRAY-TUBES |
| 00843059119558 | CLARITY PORT SYSTEM STERILIZATION TRAY-ACCESSORIES |
| 00843059119541 | CLARITY DILATOR #5, 26MM |
| 00843059119534 | CLARITY DILATOR #4, 22MM |
| 00843059119527 | CLARITY DILATOR #3, 18MM |
| 00843059119510 | CLARITY DILATOR #2, 13MM |
| 00843059119503 | CLARITY DILATOR #1, 8MM |
| 00843059119497 | CLARITY K-WIRE, 1.4MM X 9"", SINGLE USE (1PER PACK) $25.00 |
| 00843059119480 | CLARITY LIGHT CABLE, STRONG CURVE, W/TEDAN CONNECTOR |
| 00843059119473 | CLARITY TABLE CLAMP F/ ARTICULATING ARM |
| 00843059119466 | CLARITY ARTICULATING ACCESSORY ARM ANGLED COLUMN W/RACK CLAMP |
| 00843059119459 | CLARITY RETRACTOR TUBE, 26MMX120MM |
| 00843059119442 | CLARITY RETRACTOR TUBE, 26MMXII0MM |
| 00843059119435 | CLARITY RETRACTOR TUBE, 26MMXI00MM |
| 00843059119428 | CLARITY RETRACTOR TUBE, 26MMX9OMM |
| 00843059119411 | CLARITY RETRACTOR TUBE, 26MMX8OMM |
| 00843059119404 | CLARITY RETRACTOR TUBE, 26MMX7OMM |
| 00843059119398 | CLARITY RETRACTOR TUBE, 26MMX6OMM |
| 00843059119381 | CLARITY RETRACTOR TUBE, 26MMX5OMM |
| 00843059119374 | CLARITY RETRACTOR TUBE, 22MMX120MM |
| 00843059119367 | CLARITY RETRACTOR TUBE, 22MMX I IOMM |
| 00843059119350 | CLARITY RETRACTOR TUBE, 22MMXIOOMM |
| 00843059119343 | CLARITY RETRACTOR TUBE, 22MMX9OMM |
| 00843059119336 | CLARITY RETRACTOR TUBE, 22MMXSOMM |
| 00843059119329 | CLARITY RETRACTOR TUBE, 22MMX7OMM |
| 00843059119312 | CLARITY RETRACTOR TUBE, 22MMX6OMM |
| 00843059119305 | CLARITY RETRACTOR TUBE, 22MMX5OMM |
| 00843059119299 | CLARITY RETRACTOR TUBE, 18MMX120MM |
| 00843059119282 | CLARITY RETRACTOR TUBE, 18MMX I I OMM |
| 00843059119275 | CLARITY RETRACTOR TUBE, 18MMX100MM |
| 00843059119268 | CLARITY RETRACTOR TUBE, 18MMX9OMM |
| 00843059119251 | CLARITY RETRACTOR TUBE, 18MMX8OMM |
| 00843059119244 | CLARITY RETRACTOR TUBE, 18MMX7OMM |
| 00843059119237 | CLARITY RETRACTOR TUBE, 18MMX60MM |
| 00843059119220 | CLARITY RETRACTOR TUBE, 18MMX5OMM |
| 00843059124583 | CLARITY TABLE CLAMP F/ ARTICULATING ARM |
| 00843059124576 | CLARITY RETRACTOR TUBE, 22MMX60MM |
| 00843059124569 | CLARITY DILATOR #3, 18MM |