Cytosponge
GUDID 20884521767789
Cell Collection Device
Covidien LP
Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use Cytology scraper, single-use| Primary Device ID | 20884521767789 |
| NIH Device Record Key | 8e73b815-a756-4f54-8db0-cab587b30ff5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cytosponge |
| Version Model Number | CYTO-201 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 20 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521767782 [Unit of Use] |
| GS1 | 20884521767789 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181020
FDA Product Code
| EOX | Esophagoscope (flexible or rigid) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-19 |
| Device Publish Date | 2021-11-11 |
Devices Manufactured by Covidien LP
| 20884521113340 - Bolsters | 2024-07-08 Surgical Rubber Tubing |
| 10884521705272 - Situate | 2024-06-18 Detection Console 200E |
| 10884521208797 - Nellcor | 2024-06-18 Portable SpO2 Patient Monitoring System, PM10N-W, Wireless |
| 30884522005542 - Shiley | 2024-06-07 Oral/Nasal Tracheal Tube Cuffless |
| 20884521047690 - Roticulator | 2024-05-31 Articulating Stapler |
| 20884521047706 - Roticulator | 2024-05-31 Articulating Stapler |
| 20884521047713 - Roticulator | 2024-05-31 Articulating Stapler |
| 20884521047720 - Roticulator | 2024-05-31 Articulating Stapler |
Trademark Results [Cytosponge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CYTOSPONGE 79085471 4014523 Live/Registered |
United Kingdom Research and Innovation 2010-07-01 |
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