EDDA TECHNOLOGY
GUDID 00868466000237
IQQA-Guide is intended for intra-operative guidance for surgical procedures
EDDA TECHNOLOGY, INC.
Electromagnetic surgical navigation device tracking system| Primary Device ID | 00868466000237 |
| NIH Device Record Key | 5f71ecfc-449d-4198-b0fc-bebd3b3e11bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDDA TECHNOLOGY |
| Version Model Number | IQQA-Guide |
| Company DUNS | 782779701 |
| Company Name | EDDA TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com | |
| Phone | 1-609-919-9889 |
| support@edda-tech.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 8 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868466000237 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151414
FDA Product Code
| JAK | System, X-Ray, Tomography, Computed |
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 | 2016-09-20 |
On-Brand Devices [EDDA TECHNOLOGY]
| 00868466000237 | IQQA-Guide is intended for intra-operative guidance for surgical procedures |
| 00868466000220 | IQQA-BodyImaging is an image analysis software for reviewing body imaging studies (including tho |
| 00868466000213 | IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT and MR |
| 00868466000206 | IQQA-Chest is an image analysis CAD software used during the review of digital chest radiographi |
| 00868466000244 | IQQA-Liver is an image analysis software for reviewing multiphase images derived from CT scanner |
Trademark Results [EDDA TECHNOLOGY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EDDA TECHNOLOGY 87670805 5496770 Live/Registered |
EDDA Technology, Inc. 2017-11-03 |
 EDDA TECHNOLOGY 78415584 3099058 Dead/Cancelled |
EDDA Technology, Inc. 2004-05-09 |
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