Slide-on®Endosheath®
GUDID 20613994657804
SHEATH 225601 20PK SLIDE-ON ENT-5000
MEDTRONIC XOMED, INC.
Optical medical device procedural cover| Primary Device ID | 20613994657804 |
| NIH Device Record Key | 15e6ad14-1ed2-4825-8584-a42e5b1bd094 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Slide-on®Endosheath® |
| Version Model Number | 225601 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994657800 [Primary] |
| GS1 | 20613994657804 [Package] Contains: 00613994657800 Package: PK [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012543
FDA Product Code
| EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR 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 | 5 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2016-04-09 |
Devices Manufactured by MEDTRONIC XOMED, INC.
| 00763000003036 - NIM Vital™ | 2024-11-15 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0 |
| 00763000842543 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS |
| 00763000842550 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS |
| 00763000842567 - Bipolar Stimulating Probe | 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS |
| 00763000891862 - ENT NIM Electrode | 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS |
| 00763000891879 - ENT NIM Electrode | 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS |
| 00763000580483 - ENT NIM Vital | 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS |
| 00763000578022 - N/A | 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL |
Trademark Results [Slide-on]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLIDE-ON 86000629 4480837 Live/Registered |
Vision-Sciences, Inc. 2013-07-02 |
 SLIDE-ON 78523478 3045843 Dead/Cancelled |
Vision-Sciences, Inc. 2004-11-29 |
 SLIDE-ON 76471753 2750162 Live/Registered |
PGI/Phoenix Graphix, Inc. 2002-11-06 |
 SLIDE-ON 75684484 not registered Dead/Abandoned |
Vision-Sciences, Inc. 1999-04-14 |
 SLIDE-ON 74003185 1611941 Dead/Cancelled |
SHOFSTALL, ROBERT E. 1989-11-17 |
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