| Primary Device ID | 10848340015400 |
| NIH Device Record Key | 2f6cb5db-5cb9-4707-a289-e4f4293edf20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drape Sheet |
| Version Model Number | SYN-0796 |
| Company DUNS | 130785884 |
| Company Name | ADVANCE MEDICAL DESIGNS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340015403 [Primary] |
| GS1 | 10848340015400 [Package] Contains: 00848340015403 Package: [10 Units] In Commercial Distribution |
| JAA | System, x-ray, fluoroscopic, image-intensified |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
[10848340015400]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-08 |
| Device Publish Date | 2020-05-29 |
| 10848340015400 | Disposable Equipment Cover |
| 10848340013055 | Disposable Equipment Cover |
| 10848340020329 | Tape on 1 side |