| Primary Device ID | 03760246600323 | 
| NIH Device Record Key | ac68a5a5-7b28-4236-9710-300f1ed6387a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SoftFil® Classic | 
| Version Model Number | CS2250/L | 
| Company DUNS | 261575410 | 
| Company Name | SOFT MEDICAL AESTHETICS | 
| Device Count | 1 | 
| 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 | 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 03760246600323 [Package] Contains: 03760246600606 Package: Box [20 Units] In Commercial Distribution | 
| GS1 | 03760246600606 [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 | 2023-02-24 | 
| Device Publish Date | 2023-02-16 | 
| 03760246600378 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600361 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600354 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600347 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600330 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600323 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600316 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| 03760246600026 | SoftFil® Classic is a sterile and single use injection kit containing: - 1 stainless steel stan | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SOFTFIL  79307927  not registered Live/Pending | SOFT MEDICAL AESTHETICS 2020-12-09 | 
|  SOFTFIL  79116417  4468186 Live/Registered | SOFT MEDICAL AESTHETICS 2012-03-15 | 
|  SOFTFIL  79082741  4089460 Live/Registered | SOFT MEDICAL AESTHETICS 2010-04-08 |