| Primary Device ID | D903HEBEH0 |
| NIH Device Record Key | 9a7f9cd1-ae93-4026-a5ce-0d8c0b9cf691 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elements by Hedy Barrier Envelopes |
| Version Model Number | HE-BEH0 |
| Catalog Number | HE-BEH0 |
| 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 | true |
| 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 | D903HEBEH0 [Primary] |
| HIBCC | D903HEBEH01 [Package] Package: Box [100 Units] In Commercial Distribution |
| PEM | Dental Barriers And Sleeves |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-26 |
| Device Publish Date | 2019-03-18 |
| D903HEBEHO21 | Dental Barrier Sleeves for Phosphor Storage Plates, Size Large |
| D903HEBEHO11 | Dental Barrier Sleeves for Phosphor Storage, Size Medium |
| D903HEBEH0 | Dental Barriers sleeves for Phosphor Storage Plate, Size small |