| Primary Device ID | 06938695500144 |
| NIH Device Record Key | 28f95ebb-2b24-4731-87c9-7ee3ebea01dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KMC Kyphoplasty System |
| Version Model Number | FG0005-20 |
| Catalog Number | FG0005-20 |
| 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 | true |
| 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 |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938695500144 [Primary] |
| NDN | Cement, Bone, Vertebroplasty |
| 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 | 2016-12-05 |
| 06938695501523 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |
| 06938695500144 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |
| 06938695500137 | KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM |