ENDO SMARTCAP
GUDID 00677964059599
MEDIVATORS INC.
Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use| Primary Device ID | 00677964059599 |
| NIH Device Record Key | 4df9eb63-c2da-4231-bc06-81d7c4045967 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDO SMARTCAP |
| Version Model Number | 100165 |
| Company DUNS | 068199363 |
| Company Name | MEDIVATORS INC. |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00677964059599 [Primary] |
| GS1 | 10677964059596 [Package] Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 20677964059593 [Package] Package: Case [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093665
FDA Product Code
| FAJ | Cystoscope And Accessories, Flexible/Rigid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-15 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [ENDO SMARTCAP]
| 00677964059605 | 100551 |
| 00677964059599 | 100165 |
| 00677964059575 | 100165CO2 |
| 00677964059551 | 100160 |
| 00677964059537 | 100150 |
| 00677964059506 | 100150CO2 |
| 00677964059490 | 100145 |
| 00677964059469 | 100145CO2 |
| 00677964059452 | 100141 |
| 00677964059124 | 100165CO2EXT |
| 00677964059100 | 100150CO2EXT |
| 00677964059087 | 100145CO2EXT |
| 00677964057328 | 100555 |
| 40677964013766 | 100164CO2U |
| 40677964013780 | 100164CO2EXT |
| 40677964013742 | 100164CO2 |
| 40677964013728 | 100164U |
| 40677964013803 | 100164CO2EXTU |
| 40677964013704 | 100164 |
| 00724995219277 | ENDO SMARTCAP Kit for FUJIFILM 700 Series GI Endoscopes for CO2 Connection with ENDO STRATUS |
| 00724995219260 | ENDO SMARTCAP Kit for FUJIFILM GI Endoscopes for CO2 Connection with ENDO STRATUS |
| 00724995219253 | ENDO SMARTCAP Kit for certain Olympus and Pentax GI Endoscopes for CO2 Connection with ENDO STR |
| 00724995219246 | ENDO SMARTCAP Kit for certain Olympus GI Endoscopes with connection to ENDO STRATUS |
Trademark Results [ENDO SMARTCAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDO SMARTCAP 85332583 4134360 Live/Registered |
MEDIVATORS INC. 2011-05-27 |
 ENDO SMARTCAP 75239010 2206141 Live/Registered |
MEDIVATORS INC. 1997-02-10 |
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