| Primary Device ID | B504GS60450800 |
| NIH Device Record Key | 482951fe-2aad-45ae-b49e-450cb0eadf8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invotec |
| Version Model Number | 60-45080 |
| Company DUNS | 016889401 |
| Company Name | Provision |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
|---|---|
| HIBCC | B504GS60450800 [Primary] |
| GES | Blade, Scalpel |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
| B504GS60450800 | 60-45080 |
| B504GS60450500 | 60-45050 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INVOTEC 78457978 3080707 Live/Registered |
Invotec LLC 2004-07-28 |
![]() INVOTEC 77412598 3688083 Live/Registered |
Invotec International, Inc. 2008-03-04 |
![]() INVOTEC 73017636 1024547 Live/Registered |
INVO SPLINE, INC. 1974-04-01 |