| Primary Device ID | 06091403541430 |
| NIH Device Record Key | 69a6e50a-cf02-40b9-8c59-b9a2dafafa20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ebony 0.014" PTA Rx Catheter |
| Version Model Number | PC044_00-25USA |
| Company DUNS | 565545733 |
| Company Name | NATEC 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +2304663054 |
| info@natec-medical.com |
| Balloon Length | 25 Millimeter |
| Balloon Diameter | 4 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry and keep away from sunlight |
| Handling Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06091403541430 [Primary] |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-14 |
| Device Publish Date | 2018-12-12 |
| 06091403541591 | Ebony 0.014" PTA Rx Catheter, 5.00 X 25 MM |
| 06091403541430 | Ebony 0.014" PTA Rx Catheter, 4.00 X 25 MM |
| 06091403541270 | Ebony 0.014" PTA Rx Catheter, 3.00 X 25 MM |
| 06091403538669 | Ebony 0.014" PTA Rx Catheter, 5.00 X 20 MM |