| Primary Device ID | D903610HSM40 |
| NIH Device Record Key | 06f401cb-c901-4dc4-a3d4-b55c7f504419 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HedySeal Max Self-Sealing Sterilization Pouch |
| Version Model Number | 610HSM-40 |
| Catalog Number | 610HSM-40 |
| Company DUNS | 249482399 |
| Company Name | Hedy Canada |
| Device Count | 1 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D903610HSM40 [Primary] |
| HIBCC | D903610HSM401 [Package] Package: Box [200 Units] In Commercial Distribution |
| HIBCC | D903610HSM402 [Package] Contains: D903610HSM401 Package: Case [6 Units] In Commercial Distribution |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2019-01-17 |
| D903410MB2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903410MG2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903410MP2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903410MW2 - Hedy SofMask | 2020-05-06 Procedure Mask |
| D903420HFB2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903420HFG2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903420HFP2 - Hedy SoftMask | 2020-05-06 Procedure Mask |
| D903420HFW2 - Hedy SoftMask | 2020-05-06 Procedure Mask |