| Primary Device ID | 00669808002076 |
| NIH Device Record Key | 467bdef2-6fda-4125-be98-412d3a07d076 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICROFILL 30G x 25mm |
| Version Model Number | PN56048 |
| Company DUNS | 247326606 |
| Company Name | Prollenium Medical |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00669808002076 [Unit of Use] |
| GS1 | 10669808002073 [Primary] |
| GEA | Cannula, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2020-06-22 |
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| 10669808002325 - SoftFil® Precision | 2025-09-05 SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pre-hole needle in its protective |
| 10669808002394 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |
| 10669808002400 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |
| 10669808002417 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |
| 10669808002424 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |
| 10669808002431 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |
| 10669808002448 - SoftFil® EasyGuide | 2022-08-19 SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its p |