| Primary Device ID | D903410MP2 |
| NIH Device Record Key | 51f1bd21-c8d2-4b82-a0b8-1ffb89c541d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hedy SoftMask |
| Version Model Number | 410MP |
| Catalog Number | 410MP |
| Company DUNS | 249482399 |
| Company Name | Hedy Canada |
| Device Count | 50 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D903410MP0 [Unit of Use] |
| HIBCC | D903410MP1 [Primary] |
| HIBCC | D903410MP2 [Package] Contains: D903410MP1 Package: CASE [6 Units] In Commercial Distribution |
| FXX | Mask, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-11-23 |
| D903430HVB2 | Procedure Mask |
| D903420LFW2 | Procedure Mask |
| D903420LFP2 | Procedure Mask |
| D903420LFG2 | Procedure Mask |
| D903420LFB2 | Procedure Mask |
| D903420HFW2 | Procedure Mask |
| D903420HFP2 | Procedure Mask |
| D903420HFG2 | Procedure Mask |
| D903420HFB2 | Procedure Mask |
| D903410MP2 | Procedure Mask |
| D903410MG2 | Procedure Mask |
| D903410MB2 | Procedure Mask |