| Primary Device ID | D2483553190 |
| NIH Device Record Key | 0cff823a-ed65-4f34-aeea-c69285eb7401 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plast Frame |
| Version Model Number | 355319 |
| Company DUNS | 009277971 |
| Company Name | HAGER WORLDWIDE, INC. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D2483553190 [Primary] |
| EJE | FRAME, RUBBER DAM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-24 |
| Device Publish Date | 2024-04-16 |
| D24835531919 | Rubber dam frame |
| 00014081053190 | Rubber dam frame |
| D2483553190 | Rubber dam frame |