| Primary Device ID | D903610HSP102 |
| NIH Device Record Key | d415afb3-2813-4b02-99a6-01c4875723c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HedySeal PRO Self-Sealing Sterilization Pouches |
| Version Model Number | 610HSP-10 |
| Catalog Number | 610HSP-10 |
| 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 | |
| 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 | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM | |
| Phone | 905-271-1523 |
| HAMED@HEDYGS.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D903610HSP10 [Primary] |
| HIBCC | D903610HSP101 [Package] Contains: D903610HSP10 Package: BOX [200 Units] In Commercial Distribution |
| HIBCC | D903610HSP102 [Package] Contains: D903610HSP101 Package: CASE [12 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 |
| D903610HSP602 | HedySeal Pro Pouches 7.5"x13" with Class 4 Indicators |
| D903610HSP502 | HedySeal Pro Pouches 5.25"x10" with Class 4 Indicators |
| D903610HSP402 | HedySeal Pro Pouches 3.5"x9" with Class 4 Indicators |
| D903610HSP302 | HedySeal Pro Pouches 3.5"x5.25" with Class 4 Indicators |
| D903610HSP202 | HedySeal Pro Pouches 2.75"x9" with Class 4 Indicators |
| D903610HSP102 | HedySeal Pro Pouches 2.25"x4" with Class 4 Indicators |