| Primary Device ID | 00840186698178 |
| NIH Device Record Key | 8093e1ef-3c63-4604-aca7-0c33e71898c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRAPE |
| Version Model Number | DRAPE |
| Company DUNS | 083381202 |
| Company Name | BURLINGTON MEDICAL, LLC |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840186698178 [Primary] |
| EAK | Screen, Leaded, Operator Radiation Protector |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-29 |
| Device Publish Date | 2022-09-21 |
| 00840186698178 | DRAPE (DRAPE) Tailored, .5mm Regular Lead |
| 00840186699946 | DRP1000A Size Customized (GREY VINYL DRAPE ABOVE TABLE ATTACHMENT), 5mm Regular Lead |
| 00840186699939 | DRP1000A (GREY VINYL DRAPE ABOVE TABLE ATTACHMENT), 5mm Regular Lead |
| 00840186698215 | DRP2000 DRAPE-C (DRAPE ONLY-CUSTOM DOUBLE PIVOT), .5mm Regular Lead |
| 00840186698208 | DRP2000 DRAPE (DRAPE ONLY GREY VINYL DOUBLE PIVOT), .5mm Regular Lead |
| 00840186698192 | DRP1000 DRAPE-C (DRAPE ONLY-CUSTOM SINGLE PIVOT), .5mm Regular Lead |
| 00840186698185 | DRP1000 DRAPE (DRAPE ONLY-GREY VINYL SINGLE PIVOT), .5mm Regular Lead |