| Primary Device ID | 07290119640133 |
| NIH Device Record Key | bdcaf2aa-52cb-47b5-9854-7a85c81e4f1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENTire IRE System |
| Version Model Number | Power Cord |
| Catalog Number | ENTIRE005 |
| Company DUNS | 625930878 |
| Company Name | ENTIRE MEDICAL LTD |
| 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 | true |
| Serial Number | false |
| 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 | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com | |
| Phone | 1-800-4080120 |
| info@ent-ire.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290119640133 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-06 |
| Device Publish Date | 2026-02-26 |