| Primary Device ID | 00815878023262 |
| NIH Device Record Key | ef387939-bfa2-49dd-b822-fb57ca4c9a54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Phosphor Plate Barrier Envelopes (Size 2) |
| Version Model Number | 72720857 |
| Company DUNS | 027532357 |
| Company Name | BURKHART DENTAL SUPPLY CO., THE |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | (800)562-8176 |
| customerservice@burkhartdental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815878023262 [Primary] |
| IWX | Barrier, Control Panel, X-Ray, Movable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2019-11-07 |
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