| Primary Device ID | 06938695510150 |
| NIH Device Record Key | 2c549081-9f15-483f-b4c9-1ca509b76e1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balloon Catheter |
| Version Model Number | FG1001-15 |
| Catalog Number | FG1001-15 |
| Company DUNS | 528198569 |
| Company Name | Shanghai Kinetic Medical Co., 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 | true |
| 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 | +862150720558 |
| qingmeiwei@kineticmedinc.com |
| Length | 15 Millimeter |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938695510150 [Primary] |
| HRX | Arthroscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-26 |
| 06938695510204 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |
| 06938695510150 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |
| 06938695510105 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |
| 06938695537829 | Balloon Catheter, 20mm |
| 06938695537812 | Balloon Catheter, 15mm |
| 06938695537805 | Balloon Catheter, 10mm |