| Primary Device ID | 00868923000275 |
| NIH Device Record Key | 9be34228-e444-4dbc-9d7b-9f3905cdbeda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XZeal Z70 Wall VET |
| Version Model Number | Large Arm |
| Catalog Number | XZ016 |
| Company DUNS | 041863955 |
| Company Name | XZEAL TECHNOLOGIES, 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 | 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 |
| Phone | 407 483-8859 |
| info@xzeal.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868923000275 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-27 |
| 00868923000275 | The XZeal Z70 Wall VET is an X-Ray source to produce intraoral images for the diagnosis of tee |
| 00868923000268 | The XZeal Z70 Wall VET is an X-Ray source to produce intraoral images for the diagnosis of tee |
| 00868923000251 | The XZeal Z70 Wall VET is an X-Ray source to produce intraoral images for the diagnosis of tee |