| Primary Device ID | E165600137020 |
| NIH Device Record Key | d7ac9cae-635a-40da-bf86-d387e50603b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROEKO GuttaFlow®2 |
| Version Model Number | INTROKIT |
| Catalog Number | 60013702 |
| Company DUNS | 315494443 |
| Company Name | Coltène/Whaledent GmbH + Co. KG |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4973458050 |
| info.de@coltene.com |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E165600137020 [Primary] |
| KIF | Resin, Root Canal Filling |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| E165600195290 | SAMPLE |
| E165600137450 | REFILL PACK DUAL-BARREL SYRING |
| E165600137060 | REFILL PACK CAPSULES FAST |
| E165600137040 | REFILL PACK CAPSULES REGULAR |
| E165600137020 | The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + St |
| E165600137010 | STANDARD SET |
| E165600137190 | ROEKO GuttaFlow®2 Mixing tips |