| Primary Device ID | 00858964726407 |
| NIH Device Record Key | ff8a4611-21d2-42ea-824c-2dd3540f57bb |
| Commercial Distribution Discontinuation | 2017-11-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Cathet |
| Version Model Number | 900028 |
| Catalog Number | 900028 |
| Company DUNS | 431529195 |
| Company Name | G21 SRL |
| 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 |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858964726407 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-05-17 |
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| 08058964725363 - V-Access | 2024-10-24 |
| 08058964725417 - V-Access | 2024-10-24 |
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| 08058964723758 - Disp. Mixing Bowl-O | 2024-10-22 OPEN MIXING SYSTEM FOR BONE CEMENT PREPARATION |
| 08058964724427 - KeyFix Bone Drill | 2024-10-22 |