NIM-ECLIPSE®
GUDID 00643169553071
COMPUTER 945NCCPULO LOANER NOTEBOOK
MEDTRONIC XOMED, INC.
Nerve-locating system, line-powered| Primary Device ID | 00643169553071 |
| NIH Device Record Key | bcaece80-72f1-467d-9c66-9fe3c3af09cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIM-ECLIPSE® |
| Version Model Number | 945NCCPULO |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169553071 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050798
FDA Product Code
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-14 |
On-Brand Devices [NIM-ECLIPSE®]
| 00613994910967 | CONTROLLER ECLC ECLIPSE |
| 00613994910677 | COMPUTER NCCPU NOTEBOOK |
| 00643169020252 | CONTROLLER 945ECLCLO LOANER ECLIPSE |
| 00643169020191 | COMPUTER 945NCCPULO LOANER NOTEBOOK |
| 00643169786653 | CONTROLLER ECLC ECLIPSE ROHS |
| 00643169553088 | COMPUTER 945NCCPUE4LO LOANER NOTEBOOK |
| 00643169553071 | COMPUTER 945NCCPULO LOANER NOTEBOOK |
| 00643169553033 | CONTROLLER 945ECLCLO LOANER ECLIPSE |
| 00643169468573 | COMPUTER NCCPU NOTEBOOK E6540 ROHS |
| 00643169378469 | CONTROLLER ECLC ECLIPSE ROHS |
| 00643169221000 | COMPUTER NWCPU DESKTOP ENGLISH ROHS |
| 00643169177710 | COMPUTER NCCPU NOTEBOOK ROHS |
Trademark Results [NIM-ECLIPSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIM-ECLIPSE 77155368 3481613 Live/Registered |
Medtronic Xomed, Inc. 2007-04-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.