| Primary Device ID | 00616784416519 |
| NIH Device Record Key | a6a0ae7e-bd3e-41d9-8ee6-ea0f32acb46c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medi-Cut Safety Scalpel |
| Version Model Number | 4165 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 10 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784416519 [Unit of Use] |
| GS1 | 00616784416526 [Primary] |
| GS1 | 00616784416533 [Package] Contains: 00616784416526 Package: Master Shipper [20 Units] In Commercial Distribution |
| GDX | Scalpel, One-Piece |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-25 |
| Device Publish Date | 2022-04-17 |
| 00616784416519 | Medi-Cut Safety Scalpel, Sterile, # 15 |
| 00616784416113 | Medi-Cut Safety Scalpel, Sterile, #11 |
| 00616784416014 | Medi-Cut Safety Scalpel, Sterile, #10 |
| 00840117347892 | Medi-Cut Safety Scalpel, Sterile, # 15 |