EDDA TECHNOLOGY
GUDID 00868466000237
IQQA-Guide is intended for intra-operative guidance for surgical procedures
EDDA TECHNOLOGY, INC.
Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system 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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